Team science and the creation of a novel rotavirus vaccine in India: a new framework for vaccine development

Bhan, M. K.; Glass, Roger I.; Ella, Krishna M.; Bhandari, Nita; Boslego, John W.; Greenberg, Harry B.; Mohan, Krishna; Curlin, George T.; Rao, T. Srinivasa

doi:10.1016/s0140-6736(14)60191-4

Cited by 21 publications

(17 citation statements)

References 6 publications

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“…These vaccines are not widely available or affordable for the developing world. The oral rotavirus vaccine (ORV), ROTAVAC ® was developed and manufactured in India under the Indo-US Vaccine Action Program, through a unique collaborative Public-Private-Partnership [2]. On the basis of successful completion of Phase I, II and III studies in the country, this vaccine was licensed for use in India in January 2014 [3, 4, 5].…”

Section: Introductionmentioning

confidence: 99%

ROTAVAC ® does not interfere with the immune response to childhood vaccines in Indian infants: A randomized placebo controlled trial

Chandola

Taneja

Goyal

et al. 2017

Heliyon

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A phase III randomized double-blind placebo-controlled trial was conducted in the urban neighborhoods of Delhi to assess whether Oral Rotavirus Vaccine ROTAVAC® interferes with the immune response to childhood vaccines when coadministered. Infants aged 6 weeks were randomized to receive three doses of either ROTAVAC® or placebo along with childhood vaccines: Oral Polio Vaccine and vaccines against Diphtheria, Pertussis, Tetanus, Hepatitis B and Haemophilus influenza type b given as Pentavalent at 6, 10, 14 weeks of age. Blood specimens were collected from all infants at baseline and 4 weeks post dose 3 to assess the immune response to antigens in Oral Polio Vaccine, Pentavalent and ROTAVAC® vaccines. Non-inferiority of immune response to all vaccine components of the childhood vaccines when ROTAVAC® was administered concurrently was demonstrated. Non-inferior immune responses to childhood vaccines were evaluated based on the seroprotective levels of antibodies against polio types 1, 2, and 3, Diphtheria toxoid, Tetanus toxoid, Haemophilus influenza type b anti- polyribosyl ribitol phosphate antibodies and Hepatitis B antibodies; and the Geometric Mean Concentration for Pertussis. The proportion of infants who seroconverted (≥4 fold rise) was 38.6% in the ROTAVAC® group and 12.2% in the placebo group. The frequency and severity of immediate adverse events, adverse events and serious adverse events were similar in both groups. None of the five reported deaths were considered to be related to the ROTAVAC® and no case of intussusception meeting Brighton Diagnostic Certainty Level I criteria was reported.This study demonstrated that ROTAVAC® can be safely administered with childhood vaccines without interfering with the immune response to the antigens contained in these vaccines.

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Section: Introductionmentioning

confidence: 99%

ROTAVAC ® does not interfere with the immune response to childhood vaccines in Indian infants: A randomized placebo controlled trial

Chandola

Taneja

Goyal

et al. 2017

Heliyon

Self Cite

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“…The vaccine is WHO prequalified and is widely utilised in countries with endemic cholera. Second, a rotavirus vaccine was developed in partnership with Bharat Biotech, Indian Department of Biotechnology and PATH [11]. The vaccine is licensed in India for introduction in early 2016 and a dossier is ready for WHO prequalification.…”

Section: Impact Of Vaccine Procurement and Supply In Prevention Of DImentioning

confidence: 99%

“…A successful phase III clinical trial was completed in March 2013, and the world's first Sabin-IPV vaccine was launched on the Chinese Market in July 2015. IMB-CAMS is planning to increase production capacity from the current 10 million to 60 million doses per annum, to develop a combination vaccine and to obtain WHO PQ 11 to enable global supply [19].…”

Section: Novel Vaccines and Technologiesmentioning

confidence: 99%

Quality vaccines for all people

Pagliusi¹,

Ting²,

Khomvilai³

et al. 2016

Vaccine

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The Developing Countries Vaccine Manufacturers Network (DCVMN) assembled high-profile leaders from global health organisations and vaccine manufactures for its 16th Annual General Meeting to work towards a common goal: providing quality vaccines for all people. Vaccines contribute to a healthy community and robust health system; the Ebola outbreak has raised awareness of the threat and damage one single infectious disease can make, and it is clear that the world was not prepared. However, more research to better understand emerging infectious agents might lead to suitable vaccines which help prevent future outbreaks. DCVMN members presented their progress in developing novel vaccines against Dengue, HPV, Chikungunya, Cholera, cell-based influenza and other vaccines, demonstrating the commitment towards eliminating and eradicating preventable diseases worldwide through global collaboration and technology transfer. The successful introduction of novel Sabin-IPV and Oral Cholera vaccine in China and Korea respectively in 2015 was highlighted. In order to achieve global immunisation, local authorities and community leaders play an important role in the decision-making in vaccine introduction and uptake, based on the ability of vaccines to protect vaccinated people and protect non-vaccinated in the community through herd immunity. Reducing the risk of vaccine shortages can also be achieved by increasing regulatory convergence at regional and international levels. Combatting preventable diseases remains challenging, and collective efforts for improving multi-centre clinical trials, creating regional vaccine security strategies, fostering developing vaccine markets and procurement, and building trust in vaccines were discussed.

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“…This may be in the form of advanced market commitments that guarantee demand in exchange for reduced prices or creative research and development initiatives such as the partnership among Bharat Biotech, the Government of India's Department of Biotechnology, PATH, and the US National Institutes of Health that resulted in the development of the low-cost ROTAVAC vaccine. 44 …”

Section: Nonementioning

confidence: 99%