DrRMLIMS Lucknow ushers in a new era in the field of vaccine research by starting the landmark Tdap Phase -III vaccine clinical trials
DrRMLIMS Lucknow ushers in a new era in the field of vaccine research by starting the landmark Tdap Phase -III vaccine clinical trials
By Prem Kumar Jul 6, 2024, 07:36 IST
Uttar Pradesh desk Lucknow (R L Pandey). Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow, under it's Director Prof C M Singh, an avid researcher of Lancet fame, as the PI (Principal Investigator)  enthusiastically started the Phase-3 of the landmark clinical trial on vaccines having far-reaching implications on human beings.

Lohia Institute took the research to a new level by beginning to test the efficacy of  BoostagenREDTM vaccine(combined tetanus toxoid, reduced diphtheria toxoid, reduced recombinant pertussis vaccine) by BioNet-Asia compared to ADACEL©️ vaccine in the field practice area of the Institute. 

Resurgence of Pertussis , despite widespread childhood vaccination, underscores the challenges posed by waning immunity over time. Traditional acellular pertussis (aP) vaccines, while safer than whole-cell predecessors, often provide less durable protection.

Clinical studies have demonstrated BoostagenREDTM’s safety as well as its ability to induce higher and more persistent antibody levels compared to traditional vaccines against pertussis. The efficacy and safety of this vaccine is being tested in approximately 30 healthy adult participants, who have earlier received the traditional DPT. The safety and immunogenicity of this vaccine would be tested from the community.

This research was permitted for clinical trial after strict adherence to all the participant safety norms and is monitored by the Institutional Ethics Committee (IEC) of the Institute. A group of dedicated field staff consisting of doctors and paramedical workers would continuously monitor all participants who are receiving this vaccine for at least one month after administration of this vaccine. The participants would be tested for generation of immunity through blood tests, which would be done free of cost.

The trial is fully insured by ICICI Lombard and even if any side minor effect arises to any of the participants, it would be covered by the insurance and full treatment would you given free of cost the participants.

This research is a part of a multi-centric project running across the country that would establish the safety and efficacy of this vaccine in Indians.