Safety and immunogenicity of tetravalent rhesus-based rotavirus vaccine in Bangladesh

J. S. Bresee, S. El Arifeen, T. Azim, J. Chakraborty, A. W. Mounts, G. Podder, J. R. Gentsch, R. L. Ward, Robert E Black, R. I. Glass, M. Yunus

Research output: Contribution to journalArticle

Abstract

Background. Rotavirus is the most common cause of severe gastroenteritis among children worldwide. Objectives. To compare the safety, immunogenicity and shedding patterns of rhesus rotavirus (RRV)-tetravalent vaccine vs. placebo among infants in rural Bangladesh. Methods. A double blinded, placebo-controlled trial was conducted in which infants (n = 120) were randomly assigned to receive three doses of either vaccine or placebo administered at ∼6, 10 and 14 weeks of age together with routine immunizations. Data on possible adverse effects of vaccinations were collected daily for 7 days after each dose. Stool samples were collected after each dose, and serum samples were obtained before the first and after the third vaccination. Results. Fever (≥38°C), as measured by study assistants, was noted more frequently among vaccinees (15%) than among placebo recipients (2%) during the 7 days after vaccination but was not reported more frequently by parents of vaccinees vs. placebo recipients. Overall 87% of vaccinees had an antibody response (measured by IgA or anti-RRV-neutralizing antibodies) after vaccination compared with 32% of placebo recipients. Rates of seroconversion were higher among subjects with lower levels of prevaccination antibodies and those who shed rotavirus after vaccination. Vaccine strain viruses were detected in stools from placebo vaccine recipients who had evidence of IgA seroconversion. Conclusions. In this population RRV-tetravalent vaccine was comparably immunogenic and safe as in trials conducted in developed countries, where this vaccine has been proved effective in preventing severe rotavirus diarrhea. These data support continued evaluation of rotavirus vaccines in developing countries.

Original languageEnglish (US)
Pages (from-to)1136-1143
Number of pages8
JournalPediatric Infectious Disease Journal
Volume20
Issue number12
DOIs
StatePublished - 2001
Externally publishedYes

Fingerprint

Bangladesh
Placebos
Safety
Rotavirus
Vaccination
Vaccines
Rotavirus Vaccines
Gastroenteritis
rhesus rotavirus vaccine
Neutralizing Antibodies
Developed Countries
Immunoglobulin A
Developing Countries
Antibody Formation
Diarrhea
Immunization
Fever
Parents
Viruses
Antibodies

Keywords

  • Bangladesh
  • Developing countries
  • Rhesus rotavirus vaccine
  • Rotavirus
  • Rotavirus vaccine

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)

Cite this

Bresee, J. S., El Arifeen, S., Azim, T., Chakraborty, J., Mounts, A. W., Podder, G., ... Yunus, M. (2001). Safety and immunogenicity of tetravalent rhesus-based rotavirus vaccine in Bangladesh. Pediatric Infectious Disease Journal, 20(12), 1136-1143. https://doi.org/10.1097/00006454-200112000-00009

Safety and immunogenicity of tetravalent rhesus-based rotavirus vaccine in Bangladesh. / Bresee, J. S.; El Arifeen, S.; Azim, T.; Chakraborty, J.; Mounts, A. W.; Podder, G.; Gentsch, J. R.; Ward, R. L.; Black, Robert E; Glass, R. I.; Yunus, M.

In: Pediatric Infectious Disease Journal, Vol. 20, No. 12, 2001, p. 1136-1143.

Research output: Contribution to journalArticle

Bresee, JS, El Arifeen, S, Azim, T, Chakraborty, J, Mounts, AW, Podder, G, Gentsch, JR, Ward, RL, Black, RE, Glass, RI & Yunus, M 2001, 'Safety and immunogenicity of tetravalent rhesus-based rotavirus vaccine in Bangladesh', Pediatric Infectious Disease Journal, vol. 20, no. 12, pp. 1136-1143. https://doi.org/10.1097/00006454-200112000-00009
Bresee, J. S. ; El Arifeen, S. ; Azim, T. ; Chakraborty, J. ; Mounts, A. W. ; Podder, G. ; Gentsch, J. R. ; Ward, R. L. ; Black, Robert E ; Glass, R. I. ; Yunus, M. / Safety and immunogenicity of tetravalent rhesus-based rotavirus vaccine in Bangladesh. In: Pediatric Infectious Disease Journal. 2001 ; Vol. 20, No. 12. pp. 1136-1143.
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abstract = "Background. Rotavirus is the most common cause of severe gastroenteritis among children worldwide. Objectives. To compare the safety, immunogenicity and shedding patterns of rhesus rotavirus (RRV)-tetravalent vaccine vs. placebo among infants in rural Bangladesh. Methods. A double blinded, placebo-controlled trial was conducted in which infants (n = 120) were randomly assigned to receive three doses of either vaccine or placebo administered at ∼6, 10 and 14 weeks of age together with routine immunizations. Data on possible adverse effects of vaccinations were collected daily for 7 days after each dose. Stool samples were collected after each dose, and serum samples were obtained before the first and after the third vaccination. Results. Fever (≥38°C), as measured by study assistants, was noted more frequently among vaccinees (15{\%}) than among placebo recipients (2{\%}) during the 7 days after vaccination but was not reported more frequently by parents of vaccinees vs. placebo recipients. Overall 87{\%} of vaccinees had an antibody response (measured by IgA or anti-RRV-neutralizing antibodies) after vaccination compared with 32{\%} of placebo recipients. Rates of seroconversion were higher among subjects with lower levels of prevaccination antibodies and those who shed rotavirus after vaccination. Vaccine strain viruses were detected in stools from placebo vaccine recipients who had evidence of IgA seroconversion. Conclusions. In this population RRV-tetravalent vaccine was comparably immunogenic and safe as in trials conducted in developed countries, where this vaccine has been proved effective in preventing severe rotavirus diarrhea. These data support continued evaluation of rotavirus vaccines in developing countries.",
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AU - Bresee, J. S.

AU - El Arifeen, S.

AU - Azim, T.

AU - Chakraborty, J.

AU - Mounts, A. W.

AU - Podder, G.

AU - Gentsch, J. R.

AU - Ward, R. L.

AU - Black, Robert E

AU - Glass, R. I.

AU - Yunus, M.

PY - 2001

Y1 - 2001

N2 - Background. Rotavirus is the most common cause of severe gastroenteritis among children worldwide. Objectives. To compare the safety, immunogenicity and shedding patterns of rhesus rotavirus (RRV)-tetravalent vaccine vs. placebo among infants in rural Bangladesh. Methods. A double blinded, placebo-controlled trial was conducted in which infants (n = 120) were randomly assigned to receive three doses of either vaccine or placebo administered at ∼6, 10 and 14 weeks of age together with routine immunizations. Data on possible adverse effects of vaccinations were collected daily for 7 days after each dose. Stool samples were collected after each dose, and serum samples were obtained before the first and after the third vaccination. Results. Fever (≥38°C), as measured by study assistants, was noted more frequently among vaccinees (15%) than among placebo recipients (2%) during the 7 days after vaccination but was not reported more frequently by parents of vaccinees vs. placebo recipients. Overall 87% of vaccinees had an antibody response (measured by IgA or anti-RRV-neutralizing antibodies) after vaccination compared with 32% of placebo recipients. Rates of seroconversion were higher among subjects with lower levels of prevaccination antibodies and those who shed rotavirus after vaccination. Vaccine strain viruses were detected in stools from placebo vaccine recipients who had evidence of IgA seroconversion. Conclusions. In this population RRV-tetravalent vaccine was comparably immunogenic and safe as in trials conducted in developed countries, where this vaccine has been proved effective in preventing severe rotavirus diarrhea. These data support continued evaluation of rotavirus vaccines in developing countries.

AB - Background. Rotavirus is the most common cause of severe gastroenteritis among children worldwide. Objectives. To compare the safety, immunogenicity and shedding patterns of rhesus rotavirus (RRV)-tetravalent vaccine vs. placebo among infants in rural Bangladesh. Methods. A double blinded, placebo-controlled trial was conducted in which infants (n = 120) were randomly assigned to receive three doses of either vaccine or placebo administered at ∼6, 10 and 14 weeks of age together with routine immunizations. Data on possible adverse effects of vaccinations were collected daily for 7 days after each dose. Stool samples were collected after each dose, and serum samples were obtained before the first and after the third vaccination. Results. Fever (≥38°C), as measured by study assistants, was noted more frequently among vaccinees (15%) than among placebo recipients (2%) during the 7 days after vaccination but was not reported more frequently by parents of vaccinees vs. placebo recipients. Overall 87% of vaccinees had an antibody response (measured by IgA or anti-RRV-neutralizing antibodies) after vaccination compared with 32% of placebo recipients. Rates of seroconversion were higher among subjects with lower levels of prevaccination antibodies and those who shed rotavirus after vaccination. Vaccine strain viruses were detected in stools from placebo vaccine recipients who had evidence of IgA seroconversion. Conclusions. In this population RRV-tetravalent vaccine was comparably immunogenic and safe as in trials conducted in developed countries, where this vaccine has been proved effective in preventing severe rotavirus diarrhea. These data support continued evaluation of rotavirus vaccines in developing countries.

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