Tags

Type your tag names separated by a space and hit enter

A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants.
Vaccine. 2017 10 27; 35(45):6228-6237.V

Abstract

Rotavirus is the most common cause of moderate-to-severe infant diarrhoea in developing countries, resulting in enormous morbidity, mortality, and economic burden. A bovine-human reassortant pentavalent rotavirus vaccine (BRV-PV) targeting the globally most common strains was developed in India and tested in a randomized, double-blind, placebo-controlled end-point driven Phase III efficacy clinical trial implemented at six sites across India. Infants 6 to 8weeks of age were randomized (1:1) to receive three oral doses of BRV-PV or placebo at 6, 10, and 14weeks of age along with routine vaccines. Home visit surveillance was conducted to detect severe rotavirus gastroenteritis (SRVGE) and safety outcomes until the children reached two years of age. A total of 3749 infants received BRV-PV while 3751 received placebo. At the time of the primary end-point (when the minimum number of cases needed for analysis were accrued) the vaccine efficacy against SRVGE was 36% (95% CI 11.7, 53.6, p=0.0067) in the per protocol (PP) analysis, and 41.9% (95% CI 21.1, 57.3, p=0.0005) in the intent to treat (ITT) analysis. Vaccine efficacy over the entire follow-up period (until children reached two years of age) was 39.5% (95% CI 26.7, 50, p<0.0001) in the PP analysis and 38.8% (95% CI, 26.4, 49, p<0.0001) in the ITT analysis. Vaccine efficacy against the very severe rotavirus cases (VSRVGE, Vesikari score≥16) was 60.5% (95% CI 17.7, 81, p=0.0131) at the time of the primary analysis and 54.7% (95% CI 29.7, 70.8, p=0.0004) for the complete follow-period in the PP population. The incidence of solicited, unsolicited, and serious adverse events were similar in both the vaccine and placebo groups. Likewise, the number of intussusceptions and deaths were similar between both groups. Thus, BRV-PV is an effective, well tolerated and safe vaccine in Indian infants. (Trial registration: Clinical Trials.Gov [NCT 02133690] and Clinical Trial Registry of India [CTRI/2013/05/003667]).

Authors+Show Affiliations

Serum Institute of India Pvt Ltd, Pune, India. Electronic address: drpsk@seruminstitute.com.Serum Institute of India Pvt Ltd, Pune, India.PATH, Delhi, India.Shirdi Saibaba Rural Hospital, Vadu, India.Center for Health Research & Development, Society for Applied Studies, New Delhi, India.Mahatma Gandhi Institute of Medical Sciences, Sewagram, India.Government Medical College, Jammu, India.National Institute of Cholera & Enteric Diseases, Kolkata, India.Kasturba Medical College, Manipal, India.Christian Medical College, Vellore, India.Shirdi Saibaba Rural Hospital, Vadu, India.Christian Medical College, Vellore, India.Shirdi Saibaba Rural Hospital, Vadu, India.National Institute of Cholera & Enteric Diseases, Kolkata, India.National Institute of Cholera & Enteric Diseases, Kolkata, India.Government Medical College, Jammu, India.Government Medical College, Jammu, India.Serum Institute of India Pvt Ltd, Pune, India.Serum Institute of India Pvt Ltd, Pune, India.Serum Institute of India Pvt Ltd, Pune, India.PATH, Washington D.C., United States.PATH, Washington D.C., United States.PATH, Delhi, India.DiagnoSearch Pvt Ltd, Mumbai, India.PATH, Washington D.C., United States.Center for Health Research & Development, Society for Applied Studies, New Delhi, India.Center for Health Research & Development, Society for Applied Studies, New Delhi, India.Mahatma Gandhi Institute of Medical Sciences, Sewagram, India.PATH, Washington D.C., United States.No affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28967523

Citation

Kulkarni, Prasad S., et al. "A Randomized Phase III Clinical Trial to Assess the Efficacy of a Bovine-human Reassortant Pentavalent Rotavirus Vaccine in Indian Infants." Vaccine, vol. 35, no. 45, 2017, pp. 6228-6237.
Kulkarni PS, Desai S, Tewari T, et al. A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants. Vaccine. 2017;35(45):6228-6237.
Kulkarni, P. S., Desai, S., Tewari, T., Kawade, A., Goyal, N., Garg, B. S., Kumar, D., Kanungo, S., Kamat, V., Kang, G., Bavdekar, A., Babji, S., Juvekar, S., Manna, B., Dutta, S., Angurana, R., Dewan, D., Dharmadhikari, A., Zade, J. K., ... Flores, J. (2017). A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants. Vaccine, 35(45), 6228-6237. https://doi.org/10.1016/j.vaccine.2017.09.014
Kulkarni PS, et al. A Randomized Phase III Clinical Trial to Assess the Efficacy of a Bovine-human Reassortant Pentavalent Rotavirus Vaccine in Indian Infants. Vaccine. 2017 10 27;35(45):6228-6237. PubMed PMID: 28967523.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants. AU - Kulkarni,Prasad S, AU - Desai,Sajjad, AU - Tewari,Tushar, AU - Kawade,Anand, AU - Goyal,Nidhi, AU - Garg,Bishan Swarup, AU - Kumar,Dinesh, AU - Kanungo,Suman, AU - Kamat,Veena, AU - Kang,Gagandeep, AU - Bavdekar,Ashish, AU - Babji,Sudhir, AU - Juvekar,Sanjay, AU - Manna,Byomkesh, AU - Dutta,Shanta, AU - Angurana,Rama, AU - Dewan,Deepika, AU - Dharmadhikari,Abhijeet, AU - Zade,Jagdish K, AU - Dhere,Rajeev M, AU - Fix,Alan, AU - Power,Maureen, AU - Uprety,Vidyasagar, AU - Parulekar,Varsha, AU - Cho,Iksung, AU - Chandola,Temsunaro R, AU - Kedia,Vikash K, AU - Raut,Abhishek, AU - Flores,Jorge, AU - ,, Y1 - 2017/09/26/ PY - 2017/05/06/received PY - 2017/08/30/revised PY - 2017/09/01/accepted PY - 2017/10/3/pubmed PY - 2018/3/14/medline PY - 2017/10/3/entrez KW - Efficacy KW - Infants KW - Rotavirus gastroenteritis KW - Safety KW - Vaccine SP - 6228 EP - 6237 JF - Vaccine JO - Vaccine VL - 35 IS - 45 N2 - Rotavirus is the most common cause of moderate-to-severe infant diarrhoea in developing countries, resulting in enormous morbidity, mortality, and economic burden. A bovine-human reassortant pentavalent rotavirus vaccine (BRV-PV) targeting the globally most common strains was developed in India and tested in a randomized, double-blind, placebo-controlled end-point driven Phase III efficacy clinical trial implemented at six sites across India. Infants 6 to 8weeks of age were randomized (1:1) to receive three oral doses of BRV-PV or placebo at 6, 10, and 14weeks of age along with routine vaccines. Home visit surveillance was conducted to detect severe rotavirus gastroenteritis (SRVGE) and safety outcomes until the children reached two years of age. A total of 3749 infants received BRV-PV while 3751 received placebo. At the time of the primary end-point (when the minimum number of cases needed for analysis were accrued) the vaccine efficacy against SRVGE was 36% (95% CI 11.7, 53.6, p=0.0067) in the per protocol (PP) analysis, and 41.9% (95% CI 21.1, 57.3, p=0.0005) in the intent to treat (ITT) analysis. Vaccine efficacy over the entire follow-up period (until children reached two years of age) was 39.5% (95% CI 26.7, 50, p<0.0001) in the PP analysis and 38.8% (95% CI, 26.4, 49, p<0.0001) in the ITT analysis. Vaccine efficacy against the very severe rotavirus cases (VSRVGE, Vesikari score≥16) was 60.5% (95% CI 17.7, 81, p=0.0131) at the time of the primary analysis and 54.7% (95% CI 29.7, 70.8, p=0.0004) for the complete follow-period in the PP population. The incidence of solicited, unsolicited, and serious adverse events were similar in both the vaccine and placebo groups. Likewise, the number of intussusceptions and deaths were similar between both groups. Thus, BRV-PV is an effective, well tolerated and safe vaccine in Indian infants. (Trial registration: Clinical Trials.Gov [NCT 02133690] and Clinical Trial Registry of India [CTRI/2013/05/003667]). SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/28967523/A_randomized_Phase_III_clinical_trial_to_assess_the_efficacy_of_a_bovine_human_reassortant_pentavalent_rotavirus_vaccine_in_Indian_infants_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(17)31230-6 DB - PRIME DP - Unbound Medicine ER -