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Thread: Birth control: antibodies against the human pregnancy hormone

  1. #1

    Default Birth control: antibodies against the human pregnancy hormone

    Flashback 1998: United States Patent 5733553: Recombinant Birth Control Vaccine

    August 27th, 2009 With regard to human chorionic gonadotropin (hCG) and vaccines, see: Bad Blood? The Possibility of a Tainted Tetanus Toxoid Vaccine in the Philippines.
    Via: Free Patents Online:
    Population is growing at a rapid pace in many economically developing countries and there is a continuing need of an alternate method for regulation of fertility. We proposed several years back a birth control vaccine which induces the formation of antibodies against the human pregnancy hormone, the human chorionic gonadotropin (hCG). These inventions are described in patents issued in India, U.S.A. and several other countries. (Ref. EP 204566, JP 62286928, CA 1239346, U.S. Pat. No. 4,780,312, CN 8603854). We describe now another invention which generates antibody response of a long duration against hCG after a single or a limited number of injections.
    http://cryptogon.com/?p=10618
    "I think it would be a good idea." Mahatma Gandhi, when asked what he thought of Western civilization.

    The philosophers have only interpreted the world, in various ways; the point is to change it.
    Karl Marx.

    "Well, he would, wouldn't he?" Mandy Rice-Davies, 1963, replied Ms Rice Davies when the prosecuting counsel pointed out that Lord Astor denied an affair or having even met her.

  2. #2

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    Recombinant birth control vaccine
    United States Patent 5733553


    Abstract:
    A recombinant birth control vaccine comprising a beta subunit of chorionic gonadotropin, a recombinant luteinizing hormone or a mixture thereof has been developed. This recombinant birth control vaccine may also act as a vaccine against a protein or peptide unassociated with the mammalian reproductive system, such as a protein or peptide associated with a disease organism such as hepatitis B.







    Inventors:
    Talwar, Gursaran Prasad (c/o National Institute of Immunology, Shadid Jeet Singh Marg, New Delhi, IN)
    Srinivasan, Jay (Dept. of Biology, Washington University Campus, Box No:1137, One Brookings, St. Louis, MO, 63130-4899)
    Chakrabarti, Sekhar (c/o The National Institutes of Health, (Room 237, Building 4), Bethesda, MD, 20892)


    Application Number:
    08/263483

    Publication Date:
    03/31/1998

    Filing Date:
    06/21/1994

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    Primary Class:
    424/198.100

    Other Classes:
    424/227.100, 435/69.300, 435/69.100, 424/199.100

    International Classes:
    C07K14/145; C07K14/59; C12N15/863; C07K14/005; C07K14/435; A61K39/00

    Field of Search:
    424/198.1, 424/227.1, 424/199.1, 435/69.1, 435/69.3

    US Patent References:
    4738846Vaccine for vesicular stomatitis virusApril, 1988Rose et al.424/874780312Birth control vaccineOctober, 1988Talwar424/884847080Pre-S gene coded peptide hepatitis B immunogens, vaccines, diagnostics, and synthetic lipide vesicle carriersJuly, 1989Neurath et al.424/89

    Foreign References:
    WO/1986/007383December, 1986

    AUTOANTIGEN VACCINES

    Other References:
    Talwar et al., "Recent developments in immunocontraception" American Journal of Obstetrics and Gynecology (1987) 157:1075-1078.
    Lall et al., "Recombinant vaccinia virus express immunoreactive alpha subunit of ovine luteinizing hormone which associates with .beta.-hCG to generate bioactive dimer" Indian Journal of Biochemistry & Biophysics (1988) 25:510-514.
    Edwards, Rg. Conception in the Human Female, pp. 200-201, 1980, Academic Press.
    Niles, E.D., et al., "Vaccinia virus gene D8 encodes a virion transmembrane protein" J. Viol. (1988) 62(10):3772-3778.
    Chakrabarti, S., et al., "Expression of biologically active human chorionic gonadotropin and its subunits by recombinant vaccinia virus" Gene (1989) 77:89-93.
    Smith, G.L., et al., "Infectious vaccinia virus recombinants that express hepatitis B virus surface antigen"Nature (1983) 302:490-495.


    Primary Examiner:
    Feisee, Lila

    Assistant Examiner:
    Reeves, Julie E.

    Attorney, Agent or Firm:
    Morrison &Foerster


    Parent Case Data:
    This application is a continuation of application Ser. No. 07/844,566, filed May 27, 1992 now abandoned.


    Claims:
    We claim:

    1. A nucleotide sequence (I) coding for a fused peptide, the sequence consisting of: (A) a beta subunit of a mammalian gonadotropin in reading frame alignment with and followed by
    (B) the trans-membrane and cytoplasmic domains of the gene coding for Vesicular Stomatitis Virus Glycoprotein whereby when the nucleotide sequence is inserted into a virus and the virus is used to infect a host cell, the fused peptide is expressed and anchored to the host cell membrane.


    2. A nucleotide sequence (I) according to claim 1 which further includes a nucleotide sequence (II) coding for an alpha subunit of ovine luteinizing hormone inserted into a virus, whereby the alpha subunit is capable of binding to the fused peptide on co-expression with the fused peptide in the same host cell.

    3. A recombinant vaccinia virus consisting of a nucleotide sequence according to claim 1 inserted into a region of the vaccinia virus genome non-essential for survival of vaccinia virus in a host cell.

    4. A recombinant vaccinia virus consisting of a nucleotide sequence according to claim 2 inserted into a region of the vaccinia virus genome non-essential for survival of vaccinia virus in a host cell.

    5. A birth control vaccine comprising at least one recombinant virus according to claim 3.

    6. A birth control vaccine comprising at least one recombinant virus according to claim 4.

    7. A method for controlling fertility in a mammal which comprises administering an effective amount of a birth control vaccine according to claim 5.

    8. A method for controlling fertility in a mammal which comprises administering an effective amount of a birth control vaccine according to claim 6.



    Description:
    Population is growing at a rapid pace in many economically developing countries and there is a continuing need of an alternate method for regulation of fertility. We proposed several years back a birth control vaccine which induces the formation of antibodies against the human pregnancy hormone, the human chorionic gonadotropin (hCG). These inventions are described in patents issued in India, U.S.A. and several other countries. (Ref. EP 204566, JP 62286928, CA 1239346, U.S. Pat. No. 4,780,312, CN 8603854). We describe now another invention which generates antibody response of a long duration against hCG after a single or a limited number of injections.
    Whereas the possibility of controlling fertility by raising antibodies against hCG is known from our previous studies and those of others, the vaccines utilized earlier were conjugates of two or more peptides such as the natural beta hCG peptide of 145 amino acids linked to tetanus toxoid or other carriers. In another modality, the beta hCG peptide was associated with alpha oLH and then linked to carriers (Talwar et al 1988; U.S. Pat. No. 4,780,312). These vaccines demand purification and preparation of the constituent proteins from natural sources. The cost of some of these is at present very high which will be restrictive to their large scale use in family planning programs of economically developing countries. Moreover these vaccines demand three injections for primary immunization followed by a fourth as booster. A major advantage of the present embodiment is the possibility of getting satisfactory and sustained antibody response with one primary injection and at most one booster. Another interesting feature is the low cost at which this vaccine can be prepared and made available for large scale use.
    Vaccinia virus is well known as a versatile tool for molecular biologists. In the New Scientist dated 3 Dec., 1988 (Anon, p.38) an article refers to a new vaccine for rinderpest virus in cattle and states that the vaccine is a genetically engineered version of the vaccinia virus, researchers having transformed two genes coding for the coating of rinderpest virus into the vaccinia virus.
    In a Tibtech article dated January 1990, Miner et al (p. 20-25), discusses vaccinia virus as a versatile tool for molecular biologists and suggests that "the vaccinia virus system is a promising way of producing significant amounts of correctly processed and modified eukaryotic proteins in mammalian cells".
    U.S. Pat. No. 4,603,112 (inventors: E. Paoletti et al; issued: Jul. 29th, 1986) discloses methods for modifying the genome of vaccinia virus to produce recombinant vaccinia virus comprising DNA not naturally occurring in vaccinia virus. While this reference includes reference to the heterologous DNA coding for a protein which may be an antigen, it does not appear to make any suggestion that this technology is a route to birth control vaccines or birth control vaccines which also double-up as vaccines capable of raising antibodies against proteins or peptides unassociated with the mammalian reproductive system.
    PCT publication No. WO88/06626 (inventors: B.R. Bloom et al; filed: 29 Feb., 1988) relates to the use of recombinant mycobacteria as vehicles capable of expressing foreign DNA. It also indicates that such mycobacteria could be used as an anti-fertility vaccine vehicle. However, it appears to make no claim to the use of mycobacteria for control of fertility and also directs readers away from the use of vaccinia in this field pointing out alleged disadvantages on pages 4 and 5.
    Therefore there appears to be a need to provide a safe, simple and effective birth control vaccine at low cost which can also, if required, act as a vaccine against non-reproductive-system-associated disorders such as infections by bacteria and viruses. While some of the references suggest the use of vaccinia as a biotechnological tool, other references, especially Bloom et al appear strongly to discourage consideration of vaccinia. In view of the expenses involved in this type of research it therefore cannot be said that there are clear signposts to research works in this area pointing to the use of vaccinia in birth control vaccines.
    The present invention therefore provides a nucleotide sequence comprising a first sequence coding for a mammalian reproductive peptide hormone or active fragment thereof or a mammalian reproductive peptide hormone or active fragment thereof in reading frame alignment with a gene or gene fragment coding for a protein or peptide unassociated with a mammalian reproductive system and a second sequence coding for at least part of a vaccinia virus genome.
    The invention also provides a nucleotide sequence comprising a first sequence coding for (a) a beta subunit of a chorionic gonadotropin, (b) an alpha subunit of a luteinizing hormone or (c) either a beta subunit of chorionic gonadotropin or an alpha subunit of luteinizing hormone in reading frame alignment with a gene or gene fragment coding for a protein or peptide unassociated with a mammalian reproductive system and a second sequence coding for at least part of a vaccinia virus genome.
    The invention also provides a nucleotide sequence comprising a first sequence coding for (a) a beta subunit of human chorionic gonadotropin, (b) an alpha subunit of ovine luteinizing hormone or (c) either a beta subunit of human chorionic gonadotropin or an alpha subunit of ovine luteinizing hormone in reading frame alignment with a gene or gene fragment coding for a hepatitis B surface protein, and a second sequence coding for at least part of a vaccinia virus genome.
    The above nucleotide sequences are preferably inserted into a nonessential part of a vaccinia virus genome to give a recombinant vaccinia virus.
    The vaccine may consist of the genes of beta subunit of hCG fused at the DNA level with a gene fragment coding for a trans-membrane protein or peptide. A preferred trans-membrane peptide comprises 49 amino acids. A companion vaccine may consist of a physical mixture of vaccinia-beta hCG(e.g. vSS2) and vaccinia-alpha ovine luteinizing hormone(oLH)e.g. (vSL5).
    According to the present invention there is provided a birth control vaccine comprising a recombinant beta subunit of human chorionic gonadotropin, a recombinant alpha ovine luteinizing hormone or a mixture thereof.
    A preferred embodiment comprises a recombinant virus, e.g. vSS2, in which the gene for the beta subunit of hCG fused with the gene coding for a trans-membrane peptide is inserted in vaccinia virus.
    A further preferred embodiment comprises a recombinant virus such as vSL5, in which the gene for the alpha subunit of oLH is inserted in vaccinia virus.
    Another preferred embodiment comprises a recombinant virus in which a first nucleotide sequence comprises the beta unit of human chorionic gonadotropin in reading frame alignment with a gene coding for the middle protein of hepatitis B surface protein. Other proteins from other organisms, especially pathogens, or even synthetic sequences can be coded in place of hepatitis B proteins.
    BRIEF DESCRIPTION OF THE DRAWINGS
    In drawings which illustrate embodiments of the invention;
    FIG. 1 shows the strategy for the construction of anchored beta hCG;
    FIG. 2 shows the strategy for the insertion of alpha oLH gene into vaccinia virus; and,
    FIG. 3 demonstrates the anti hCG response in terms of antigen binding capacity. The figure shows typical antibody response in four rats given a single injection of vSS2 recombinant vaccine at a dose of 10 pfu (plaque forming units). Each animal response with antibodies in circulation measurable at the end of four weeks. The titers ranged from 100 to 900 ng/ml and are distinctly above the threshold value of 20 ng/ml considered to be protective against pregnancy. The titers were sustained over 12 weeks of observation.
    FIGS. 4a to 4h show development of hCG antibodies in 8 bonnet monkeys injected with vSS2 recombinant vaccine.
    FIG. 5 shows the strategy for the construction of BhCG-HBsAg. The final plasmid, pSS4 is shown along with the junction sequences between BhCG and HBsAg.
    FIG. 6 shows a southern blot of pSS4. Nick-translated S gene was used as the probe and washed at high stringency.
    FIG. 7 shows subcloning of hepatitis B genome in pUC plasmids.
    FIG. 8 gives assay results for BhCG and HBsAg. On the X-axis are the three parallel purified recombinants of the virus vSS4 (1,2 and 3) along with vSS2, an internal control and Abbott's positive and negative controls.
    FIG. 9 shows development of hCG antibodies in 7 rats injected with vSS4 recombinant vaccine.
    EXAMPLE 1
    Synthesis and Utility of Recombinant Anti-hcG Vaccine
    The construction strategy of vSS2: The virus containing the anchored beta hCG was made by an in-frame fusion of the trans- membrane and cytoplasmic domains of the gene coding for vesicular stomatitis virus glycoprotein (VSVg) to the 3 ' end of the beta hCG cDNA (FIG. 1). The VSVg gene was digested with Alu I and Xho I to release the 249 bp membrane anchor sequence. This fragment was eluted out from an acrylamide gel, klenow filled and ligated to the Sma I cut vector pSS I, the latter was prepared by the procedure described by us previously (Chakrabartit et al 1989). Orientation of the anchor sequence with reference to beta hCG was checked by suitable restriction enzyme digestions. This was used to transfect CV-1 cells pre-infected with wild type virus and the recombinants were picked up by visual screening for the blue plaques by the technique described elsewhere.
    Assay for beta hCG
    The expression of beta hCG was detected in the pellet of the vSS2 infected cells by a competitive radio-immunoassay using mouse monoclonal antibodies raised against beta hCG. The cellular localisation of hCG was determined by immunofluorescence technique using anti beta hCG MoAb followed by rabbit anti mouse conjugated to FITC.
    Immunogenic properties: A single intra-dermal injection of 10 8 pfu of vSS2 elicited the formation of antibodies in rats which reacted with hCG (FIG. 3) and prevented effectively the binding of hCG to receptors on target tissue. The antibodies were detectable within four weeks. The titers were sustained without a decline over a period of several months.
    Antibody titers in monkeys immunized with recombinant anti hCG vaccine (vSS2):
    Bonnet monkeys (Mecacca radiata) were immunized intradermally with 10 8 pfu of the recombinant vaccine. Two immunizations were done at 3 months interval (day 0 to 95). Four months later (day 226), a booster injection of 100 ug of beta hCG adsorbed on alum was given intramuscularly. Anti hCG antibodies were measured (.quadrature.--.quadrature.) by radio-immunoassay (see Om Singh et al). These are expressed on the ordinate on a logarithmic scale. The antibody titers were measurable after the first immunization with the recombinant vaccine. Their titers after two primary and a booster injection increased to very high levels ranging from 3,200 to 14,000 ng of hCG binding capacity per ml. These antibodies had high affinity (ka=10 -11 LM). The antibodies were competent to prevent the binding of hCG to the target tissue receptors as determined by competitive radio receptor assays (+--+). The competence of the antibodies in neutralizing the bioefficacy of hCG indicates the efficacy of immunization with such vaccines in order to intercept events supported by hCG, such as the establishment and sustenance of early pregnancy.
    FIG. 4 gives data in eight monkeys to demonstrate the consistency of the phenomenon. These experiments also demonstrate the immunogenicity of these products not only in rodents but also in primates (and, by extension, humans).
    To date, the best results in both monkeys and rats have been obtained with 10 8 pfu. An operating range runs from about 10 9 down to about 10 4 pfu, preferably of the order of 10 7 to 10 8 pfu. Interestingly, dose does not appear to work in this case on a body weight basis and this may be related to the use of live vaccine. Attenuation by passaging may be useful to avoid possible side effects.
    EXAMPLE 2
    Synthesis and Utility of Anti-oLH Vaccine
    Construction of vSL5: The alpha oLH cDNA was cut out by the restriction enzyme Bgl II from a previously described vector (Lall et al 1988). This fragment was klenow filled, ligated to 8-mer Eco RI linkers and cloned into the unique Eco RI site of the vaccinia vector pSC45 (FIG. 2). The final plasmid, pSL5, was characterised in detail with respect to the correct orientation of the alpha oLH gene by multiple restriction enzyme digestions and Southern hybridization. This plasmid was subsequently used in DNA transfection to construct the recombinant virus vSL5 as described earlier.
    Assay for alpha oLH
    The medium of the cells infected with recombinant virus vSL5, was assayed for the presence of alpha oLH by a competitive radio-immunoassay using anti alpha oLH antibodies raised in monkeys. The expression of alpha oLH was quantitated using a standard subunit peptide. The presence of alpha oLH could be detected within three hours of infection and was found to be 280 ng/ml/310 6 cells in 24 hours.
    EXAMPLE 3
    Production of Mixed Recombinant Vaccines
    Biological activity: The alpha oLH subunit associates with beta hCG to form a hetero-dimer. The ability of this hetero-dimer to stimulate steroidogenesis in a Leydig cell system is well-established (Talwar et al., 1988). In order to show that the recombinant alpha oLH-beta hCG hetero-dimer retains its biological activity, a co-infection of viruses vSS1 and vSL5 was done in the CV1 cells and the supernatant, collected 24h post-infection was used in a Leydig cell bio-assay. The steroidogenesis elicited by the vaccinia expressed alpha oLH-beta hCG hetero-dimer was greater than the native hCG dimer indicating the correct and full length expression of the two peptides.
    A similar and somewhat bio-effectively better immune-response to that shown by construct vSS2 alone could be generated by using a mixture of the constructs vSS2 and vSL5. It is known from other studies that the antibodies generated by a heterospecies dimer of beta hCG and alpha oLH have about 25% better bio-efficacy as a function of their immunological titers as compared to those generated to beta hCG alone.
    EXAMPLE 4
    Production of a Recombinant Birth Control Vaccine Also Having Other Antigenic Properties Associated With The Same Nucleotide Sequence
    The gene for beta hCG together with sequences enabling it to anchor on the membrane of the infected cells is one effective modality to induce antibodies against hCG.
    Another modality which results in production of hCG antibodies together with protection against hepatitis B viral infection is as follows:
    The gene for beta hCG is cloned in right alignment and in-frame with the gene coding for hepatitis B surface protein, which includes the portion coding for the S region of the protein as well as the pre S2 region. The manner in which this construct is prepared is exemplified below.
    Cloning of BhCG-HBsAq into Vaccinia,
    The vector pSSI (see above and FIG. 1), containing beta hCG cDNA in a vaccinia vector, was digested with the restriction endonuclease, Sma I, which cuts just upstream of the BhCG termination codon. The Hind III fragment coding for the entire middle protein of hepatitis B surface protein (pre S +S region) was digested out from the intermediate vector pJS5 (described below), klenow filled and ligated to the Sma I cut pSS1 to give rise to the plasmid pSS4. (FIG. 5). The orientation of the hepatitis B surface protein gene in relation to beta hCG was verified by various restriction enzyme digestions and Southern blotting (FIG. 6). This plasmid was used to make the recombinant vaccinia virus and the recombinants (vSS4) were picked up as described earlier. Cloning of the Intermediate Vector pJS5 :
    Hepatitis B genome was cut out of the plasmid pCF80 by EcoRI digestion. The 3.2 kb EcoRI fragment was purified from an agarose gel and was further digested with Nco I to give rise to a fragment of approximately 1.9 kb (coding for X and C proteins) and a fragment of approximately 1.3 kb, (coding for pre S2+S protein of hepatitis B.) 10 mer Hind III linkers were ligated to the 1.3 kb fragment and cloned into the Hind III site of the plasmid pUC 18 to give rise to the plasmids pJS5 & pJS6. The 1.3 kb EcoRI-NcoI fragment was blunt ended and cloned into the Sma I site of the plasmid pUC 19 to give rise to the plasmids pJS7 pJS8 (FIG. 7).
    Assay for beta hCG HBsAq:
    This recombinant virus (vSS4) expresses both beta hCG, as detected in a competitive radio-immunoassay, as well the surface antigen (HBsAg) as measured bY Abbott's monoclonal antibody based Elisa (FIG. 8).
    Immunogenicity of Beta hCG-HBsAg Constructs in Vaccinia:
    Rats immunized with the above construct by intra-dermal route developed antibodies against hCG (FIG. 9). Being given that antibodies against hCG have been demonstrated to be protective against pregnancy, this version of the vaccine is also usable for control of fertility in women. Furthermore in view of the fact that the gene of Hepatitis B surface protein is also present in the recombinant organism means that the vaccine has immunoprophylactic benefit in a recipient against hepatitis.
    The new live recombinant vaccines described here were well tolerated, no side effects were observed during standard acute and subacute toxicology studies in the two animal species studied to date. These vaccines can be employed with conventional pharmaceutically acceptable diluents.
    REFERENCES NOT DETAILED IN THE DISCLOSURE
    S. Chakrabarti, Srinivasan. J, L. Lall, L. V. Rao and G. P. Talwar: Expression of biologically active human chorionic gonadotropin and its subunits by recombinant vaccinia virus. Gene, 77, (1989) 87-93.
    Chakrabarti S, Brechling K and Moss B.: Vaccinia virus expression vector: Co-expression of B-galactosidase provides visual screening of recombinant viral plagues. Mol. Cell. Biol., 5, (1985) 3403-3409.
    Jain S. K, Chin W. W and Talwar. G. P.: Isolation and characterization of cDNA clones for and B subunits of ovine luteinizing hormone. J. Biosci., 12, (1987) 349-357.
    Lavanya Lall, J. Srinivasan, L. V. Rao, S. K. Jain, G. P. Talwar and S. Chakrabarti.: Recombinant vaccinia virus expresses immunoreactive alpha subunit of Ovine Luteinizing Hormone which associates with B-hCG to generate bioactive dimer. Indian J. Biochem. Biophy., 25, (1988) 510-514.
    Talwar G. P, Om Singh and Rao L. V.: An improved immunogen for anti-hCG vaccine eliciting antibodies reactive with conformation native to the hormone without cross-reaction with hFSH and hTSH. J. Repro. Immu., 13, (1988) 53-63.
    Om Singh, N. C. Sharma, L. V, Rao, A. Alam A. Gaur and G. P. Talwar (1989): Antibody response and characteristics of antibodies in women immunized with three contraceptive vaccines inducing antibodies against human chorionic gonadotropin. Fertility and St rility: vol. 52, No. 5, 739-744.
    "I think it would be a good idea." Mahatma Gandhi, when asked what he thought of Western civilization.

    The philosophers have only interpreted the world, in various ways; the point is to change it.
    Karl Marx.

    "Well, he would, wouldn't he?" Mandy Rice-Davies, 1963, replied Ms Rice Davies when the prosecuting counsel pointed out that Lord Astor denied an affair or having even met her.

  3. #3

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    Bad Blood? The Possibility of a Tainted Tetanus Toxoid Vaccine in the Philippines
    Possibly tainted vaccine may be tip of the iceburg
    By David Morrison
    Population Research Institute Review, November/December, 1996, page 3.
    Philippine women may have been unwittingly vaccinated against their own children, a recent study conducted by the Philippine
    Medical Association (PMA) has indicated.1

    The study tested random samples of a tetanus vaccine for the presence of human chorionic gonadotropin (hCG), a hormone
    essential to the establishment and maintenance of pregnancy. Produced by the embryo after conception, hCG triggers the
    production of progesterone in the mother's body which, in turn, thickens the uterine endometrium and prepares it for
    implantation. By linking hCG with tetanus antigens in a vaccine, researchers fool a woman's immune system into not only
    producing antibodies against tetanus, but against hCG as well, essentially making her allergic to her embryo's chemical
    signal. Once her immune system is sufficiently stimulated against hCG, a woman will spontaneously abort any child she
    conceives. The PMA's positive test results indicate that just such an abortifacient may have been administered to Philippine
    women without their consent.

    The PMA notified the Philippine Department of Health (PDOH) of these findings in a 16 September letter signed by the
    researchers and certified by its President. Using a immunological assay developed by the Food and Drug Administration in the
    United States, a three-doctor research panel tested forty-seven vials of tetanus vaccine collected at random from various
    health centers in Luzon and Mindanao.2 Nine were found to contain hCG in levels ranging from 0.191680 mIU/ml to 3.046061
    mIU/ml. These vaccines, most of which were labeled as of Canadian origin, were supplied by the World Health Organization as
    part of a WHO-sponsored vaccination program.


    The positive tests for hCG in the vaccine brings to a close the first stage of the two-part study commissioned by the
    Philippine Department of Health. The second stage calls for the blood of vaccinated women to be tested for antibodies to
    hCG. Once this second round of testing is complete, Philippine authorities will have a much clearer idea of whether any
    Filipinas have been chemically sterilized and, if so, how many.

    Individual women who have lost children to miscarriage after accepting the anti tetanus vaccine have already been found to
    have antibodies to hCG. Dr. Vilma Gonzales had two miscarriages after receiving the tetanus vaccine and became suspicious.
    She had her blood tested for anti-hCG antibodies and found, to her great sorrow, that these were present "in high levels."
    As she later told a British Broadcasting reporter:

    Women should have been told that the injection would cause miscarriage and, in the end, infertility. The Department of
    Health should have asked beforehand, so that only those who didn't want to have children had the injection. I really hope
    and pray to God that I will still have a baby and get a normal pregnancy. And I am still hopeful that the Department of
    Health will find an antidote to the antibodies as well.3

    The possibility that Philippine women were being covertly dosed with an abortifacient vaccine got widespread attention after
    Human Life International, an international pro-life group, reported on peculiar tetanus vaccination programs in the
    Philippines, Mexico and Nicaragua. The World Health Organization4 only targeted women between the ages of 15 and 45 - the
    child bearing years - for repeated tetanus vaccinations. This, by itself, might not have aroused too much suspicion - and
    WHO officials hotly denied any wrongdoing. When WHO's research history on "reproductive immunology" came to light, however,
    the possibility became too great to ignore.

    WHO's hCG research
    For over 20 years, World Health Organization has been deeply involved in researching ways to make women's bodies reject
    their own children. As early as the 1970's, WHO funded research in this area by researchers in India and the United States.5
    Though WHO later cut off funding for the 'Indian branch' of abortifacient vaccine research, it continues to fund US
    efforts.6 Current WHO-funded research in the United States, according to a leading researcher, has "moved on" from tetanus
    to diphtheria as the antigen link. For even greater efficiency and wider reach, the possibility of doing away with the
    antigen link altogether is also being explored.7

    According to Dr. Vernon Stevens, a researcher at Ohio State, the effort to make millions of women allergic to their children
    faces three primary research obstacles. First, current abortifacient vaccine models require 2 to 4 initial shots to boost
    immune levels and then booster shots at three to six month intervals. Second, the hCG vaccine does not always "take" in all
    women. In recent Phase II (efficacy) trials of one possible vaccine, for example, only 60% of women vaccinated were later
    found to have highly effective levels of anti-hCG antibodies.8 And finally, according to Stevens, the current vaccines under
    research are just too expensive for widespread use.

    "Vaccines that are manufactured for distribution and use by the general population must be produced in high quality and at a
    cost affordable to most users, particularly in developing countries where the need for new methods is most acute,"9 Stevens
    wrote. The current WHO funded research in the United States aims to address this and the other problems.

    Indian vaccine research
    While WHO funds US - based research into abortifacient vaccines, the Population Council and the International Development
    Research Center (IDRC),10 based in Ottawa, Canada, have been funding the even more controversial efforts of Dr. Gursaran
    Prasad Talwar. Talwar, the founder of the National Institute of Immunology in New Delhi, India, is generally acknowledged to
    be the "father" of research into abortifacient vaccines.

    Talwar and WHO officially parted company when Talwar's approach, based on using a longer segment of the crucial hCG molecule
    to generate the needed antibodies, was thought to be too close to the segments of related hormones and therefore thought to
    carry a greater risk of side-effects - side effects which, Talwar claims, never appeared.11 The Population Council also
    directly funded Talwar's research until the United States' "Mexico City" policy forced it to reconsider its support for the
    development of something as obviously abortifacient as his vaccine.

    At that point the IDRC stepped in and began funding efficacy trials for Talwar's vaccines.12 In these trials Talwar claims
    that 118 of 148 women vaccinated, or about 80%, produced levels of hCG antibodies sufficient to abort their children and
    they maintained those levels for between 6 months and two years. This result has increased optimism and enthusiasm for the
    Talwar vaccine and drawn three more labs into the research effort.

    Although Talwar's efforts have many champions, he is not without his critics. Controversy seems to follow him wherever he
    goes. He has been accused both of stealing compounds from other researchers13 and of not following established medical
    protocols for vaccine research.14

    But from the point of view of numerous Filipinas, the most disturbing allegation against Talwar is that he has, in the past,
    tested his abortifacient vaccines on women without firsting testing them on animals.15 Both Indian researchers and WHO
    officials are on record as declaring that such abuses have occurred. Their testimony has helped fire opposition to the
    vaccine, especially on the part of women's groups.16

    The blood of the women, in the end, will declare the truth. These abortifacient vaccines leave 'fingerprints.' Even positive
    tests for antibodies will not tell the whole story, however. For these tests, even when multiplied by the hundreds and
    thousands, cannot possibly convey the depth of misanthropy - particularly towards people in the developing world -
    represented by over twenty years of planning, funding, studying and publishing on abortifacient vaccines. Fifty years ago,
    at Nuremburg, the so-called "civilized" world looked into the depths of Nazi Germany's eugenic nightmare and shrank back in
    horror. Vaccines which induce women to abort their own children deserve the same response.

    Endnotes
    1. Letter from the Philippine Medical Association to Philippine Secretary of Health, 16 September, 1996.
    2. Ibid.
    3.British Broadcasting Corporation Horizon Series The Human Laboratory first aired in Britain on 8 November 1995.
    4.James Miller, "Baby killing vaccine: is it being stealth tested?" HLI Reports, June/July 1995, p. 1.
    5. Madhusree Mukerjee, "Profile: Gursaran Prasad Talwar," Scientific American, July 1996.
    6. Vernon Stevens, "Progress in the development of human chorionic gonadotropin antifertility vaccines," American Journal of
    Reproductive Immunology, 1996, volume 35, 148-155.

    7. Vernon Stevens personal communication, 16 October 1996.
    8. Vernon Stevens, "Progress in the development of human chorionic gonadotropin antifertility vaccines."
    9. Ibid.
    10. Jayaraman, "India forges ahead with contraceptive vaccine," Nature Medicine, July 1995, 609 - 610.
    11. Mukerjee.
    12. Jayaraman.
    13. Mukerjee.
    14. Vernon Stevens, personal communication, 16 October 1996. Stevens related how research conducted under Talwar at National
    Immunology Institute differed from US research in that researchers did not always "go back to square one" if they
    reconfigured a vaccine conjugate.

    15. Mukerjee.
    16. Ibid.

    http://www.akha.org/content/medicaldocuments/tetanustoxoidphilippines.html
    "I think it would be a good idea." Mahatma Gandhi, when asked what he thought of Western civilization.

    The philosophers have only interpreted the world, in various ways; the point is to change it.
    Karl Marx.

    "Well, he would, wouldn't he?" Mandy Rice-Davies, 1963, replied Ms Rice Davies when the prosecuting counsel pointed out that Lord Astor denied an affair or having even met her.

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