ROTAVAC® does not interfere with the immune response to childhood vaccines in Indian infants: A randomized placebo controlled trial
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...
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| Format: | Article |
| Language: | English |
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Elsevier
2017-05-01
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| Series: | Heliyon |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S240584401730289X |
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| author | Temsunaro Rongsen Chandola Sunita Taneja Nidhi Goyal Kalpana Antony Kiran Bhatia Deepak More Nita Bhandari Iksung Cho Krishna Mohan Sai Prasad GVJA Harshavardhan Tataji Surender Rao Sudhanshu Vrati Maharaj Kishan Bhan |
| author_facet | Temsunaro Rongsen Chandola Sunita Taneja Nidhi Goyal Kalpana Antony Kiran Bhatia Deepak More Nita Bhandari Iksung Cho Krishna Mohan Sai Prasad GVJA Harshavardhan Tataji Surender Rao Sudhanshu Vrati Maharaj Kishan Bhan |
| author_sort | Temsunaro Rongsen Chandola |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T03:30:01Z |
| format | Article |
| id | doaj.art-eab858c8b6394615ae179d58778d4a4f |
| institution | Directory Open Access Journal |
| issn | 2405-8440 |
| language | English |
| last_indexed | 2024-04-13T03:30:01Z |
| publishDate | 2017-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Heliyon |
| spelling | doaj.art-eab858c8b6394615ae179d58778d4a4f2022-12-22T03:04:32ZengElsevierHeliyon2405-84402017-05-0135e00302ROTAVAC® does not interfere with the immune response to childhood vaccines in Indian infants: A randomized placebo controlled trialTemsunaro Rongsen Chandola0Sunita Taneja1Nidhi Goyal2Kalpana Antony3Kiran Bhatia4Deepak More5Nita Bhandari6Iksung Cho7Krishna Mohan8Sai Prasad9GVJA Harshavardhan10Tataji Surender Rao11Sudhanshu Vrati12Maharaj Kishan Bhan13Centre for Health Research and Development, Society for Applied Studies, New Delhi, India; Population Science Partnership Centre, Translational Health Science and Technology Institute, Faridabad, Haryana, IndiaCentre for Health Research and Development, Society for Applied Studies, New Delhi, India; Population Science Partnership Centre, Translational Health Science and Technology Institute, Faridabad, Haryana, IndiaCentre for Health Research and Development, Society for Applied Studies, New Delhi, India; Population Science Partnership Centre, Translational Health Science and Technology Institute, Faridabad, Haryana, IndiaPATH, Mumbai, IndiaCentre for Health Research and Development, Society for Applied Studies, New Delhi, India; Population Science Partnership Centre, Translational Health Science and Technology Institute, Faridabad, Haryana, IndiaPATH, Mumbai, India; Centre for Health Research and Development, Society for Applied Studies, New Delhi, IndiaCentre for Health Research and Development, Society for Applied Studies, New Delhi, India; Population Science Partnership Centre, Translational Health Science and Technology Institute, Faridabad, Haryana, IndiaIndependent Statistical Consultant, Potomac, MD, USABharat Biotech International Limited, Genome Valley, Andhra Pradesh, IndiaBharat Biotech International Limited, Genome Valley, Andhra Pradesh, IndiaBharat Biotech International Limited, Genome Valley, Andhra Pradesh, IndiaClinical Development Services Agency, Translational Health Science and Technology Institute, NCR-Biotech Science Cluster, Faridabad, Haryana, India; Department of Biotechnology Ministry of Science and Technology, Government of IndiaVaccine and Infectious Disease Research Centre, Translational Health Science and Technology Institute, Faridabad, Haryana, IndiaIndian Institute of Technology, New Delhi, India; Corresponding author at: National Science Professor, Indian Institute of Technology (Delhi), F-14, Hauz Khas Enclave, New Delhi-110016, India.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.http://www.sciencedirect.com/science/article/pii/S240584401730289XPediatricsInfectious diseaseImmunologyVaccines |
| spellingShingle | Temsunaro Rongsen Chandola Sunita Taneja Nidhi Goyal Kalpana Antony Kiran Bhatia Deepak More Nita Bhandari Iksung Cho Krishna Mohan Sai Prasad GVJA Harshavardhan Tataji Surender Rao Sudhanshu Vrati Maharaj Kishan Bhan ROTAVAC® does not interfere with the immune response to childhood vaccines in Indian infants: A randomized placebo controlled trial Heliyon Pediatrics Infectious disease Immunology Vaccines |
| title | ROTAVAC® does not interfere with the immune response to childhood vaccines in Indian infants: A randomized placebo controlled trial |
| title_full | ROTAVAC® does not interfere with the immune response to childhood vaccines in Indian infants: A randomized placebo controlled trial |
| title_fullStr | ROTAVAC® does not interfere with the immune response to childhood vaccines in Indian infants: A randomized placebo controlled trial |
| title_full_unstemmed | ROTAVAC® does not interfere with the immune response to childhood vaccines in Indian infants: A randomized placebo controlled trial |
| title_short | ROTAVAC® does not interfere with the immune response to childhood vaccines in Indian infants: A randomized placebo controlled trial |
| title_sort | rotavac r does not interfere with the immune response to childhood vaccines in indian infants a randomized placebo controlled trial |
| topic | Pediatrics Infectious disease Immunology Vaccines |
| url | http://www.sciencedirect.com/science/article/pii/S240584401730289X |
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