Prevention of nodules and enhancement of antibody response to genetically engineered recombinant vaccine against Human Chorionic Gonadotropin (hCG) for contraception.

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
Read More Add to Saved list
  • Additional Information
    • Source:
      Publisher: Informa Healthcare Country of Publication: England NLM ID: 9712127 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1473-0782 (Electronic) Linking ISSN: 13625187 NLM ISO Abbreviation: Eur J Contracept Reprod Health Care Subsets: MEDLINE
    • Publication Information:
      Publication: London : Informa Healthcare
      Original Publication: Carnforth, Lancs, UK ; Pearl River, N.Y. : Parthenon Pub. Group, c1996-
    • Subject Terms:
      Vaccines, Synthetic*/immunology ; Chorionic Gonadotropin*/immunology; Animals ; Female ; Mice ; Contraception, Immunologic/methods ; Vaccines, Contraceptive/immunology ; Antibody Formation/drug effects ; Humans ; Mice, Inbred BALB C ; Adjuvants, Immunologic ; Injection Site Reaction ; Genetic Engineering ; Injections, Intramuscular ; Chorionic Gonadotropin, beta Subunit, Human/immunology
    • Abstract:
      Objective: Human Chorionic Gonadotropin (hCG) plays a crucial role in embryo implantation and in maintenance of pregnancy. An immuno-contraceptive approach involves the use of a recombinant hCGβ-LTB vaccine formulated with adjuvant Mycobacterium indicus pranii (MIP), to prevent pregnancy without disturbing ovulation, hormonal profiles, and menstrual cycles in women. The present work in mice was designed to address issues encountered in clinical trials conducted with hCGβ-LTB vaccine, with focus on two primary concerns. Firstly, it aimed to determine the optimal vaccine dosage required to induce a high level of anti-hCG antibodies. Secondly, it aimed to assess the safety profile of the vaccine, specifically injection site reactions in the form of nodules, observed in some of the subjects.
      Methods and Results: Studies undertaken indicate that a 2 µg dose of the protein version of the vaccine, administered in mice through the intramuscular route, can induce high anti-hCG titres. Furthermore, administering a booster dose enhances the antibody response. Our findings suggest that the concentration and frequency of administration of the adjuvant MIP can also be reduced without compromising vaccine efficacy.
      Conclusion: The issue of nodule formation at the injection site can be mitigated either by administering the vaccine along with MIP intramuscularly or injecting hCG vaccine and MIP at separate intradermal sites. Thus, protein vaccine administered at a 2µg dose via the intramuscular route addresses both efficacy and safety concerns.
    • Contributed Indexing:
      Keywords: MIP; contraception; hCG; nodule; recombinant vaccine
      Local Abstract: [plain-language-summary] The Phase I/II clinical trials initiated with the recombinant hCG vaccine in women revealed inadequate antibody titres in all subjects, alongside the development of nodules at the injection sites in some participants. Studies were undertaken in mice to propose potential strategies for mitigating injection site reactions and enhancing the antibody response. It was concluded that the optimum dose of the protein version of the vaccine to get high antibody titres, is 2 µg administered intramuscularly while upholding safety standards.
    • Accession Number:
      0 (Vaccines, Synthetic)
      0 (Chorionic Gonadotropin)
      0 (Vaccines, Contraceptive)
      0 (Adjuvants, Immunologic)
      0 (Chorionic Gonadotropin, beta Subunit, Human)
    • Publication Date:
      Date Created: 20240621 Date Completed: 20240722 Latest Revision: 20240821
    • Publication Date:
      20240821
    • Accession Number:
      10.1080/13625187.2024.2359127
    • Accession Number:
      38904162