Dataset Information

Safety and immunogenicity of Vi-typhoid conjugate vaccine co-administration with routine 9-month vaccination in Burkina Faso: A randomized controlled phase 2 trial.

ABSTRACT:

Objectives

In 2017, the World Health Organisation (WHO) pre-qualified a single-dose typhoid conjugate vaccine (TCV) and identified TCV co-administration studies as a research priority. Accordingly, we tested co-administration of Typbar TCV® (Bharat Biotech International) with measles-rubella (MR) and yellow fever (YF) vaccines.

Methods

We conducted a randomized, double-blind, and controlled, phase 2 trial in Ouagadougou, Burkina Faso. Healthy children aged 9-11 months were randomized 1:1 to receive TCV (Group 1) or control vaccine (inactivated polio vaccine (IPV), Group 2). Vaccines were administered intramuscularly with routine MR and YF vaccines. Safety was assessed by (1) local and systemic reactions on days 0, 3, and 7; (2) unsolicited adverse events within 28 days; and (3) serious adverse events (SAEs) within six months after immunization.

Results

We enrolled, randomized, and vaccinated 100 eligible children (49 Group 1 and 51 Group 2). Safety outcomes occurred with similar frequency in both groups: local/solicited reactions (Group 1: 1/49, Group 2: 3/50), systemic/solicited reactions (Group 1: 4/49, Group 2: 9/50), unsolicited adverse events (Group 1: 26/49, Group 2: 33/51), and SAEs (Group 1: 2/49, Group 2: 3/51). TCV conferred robust immunogenicity without interference with MR or YF vaccines.

Conclusion

TCV can be safely co-administered with MR and YF vaccines to children at the 9-month vaccination visit.

SUBMITTER: Sirima SB

PROVIDER: S-EPMC8298254 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Publications

Safety and immunogenicity of Vi-typhoid conjugate vaccine co-administration with routine 9-month vaccination in Burkina Faso: A randomized controlled phase 2 trial.

Sirima Sodiomon B SB Ouedraogo Alphonse A Barry Nouhoun N Siribie Mohamadou M Tiono Alfred A Nébié Issa I Konaté Amadou A Berges Gloria Damoaliga GD Diarra Amidou A Ouedraogo Moussa M Bougouma Edith C EC Soulama Issiaka I Hema Alimatou A Datta Shrimati S Liang Yuanyuan Y Rotrosen Elizabeth T ET Tracy J Kathleen JK Jamka Leslie P LP Oshinsky Jennifer J JJ Pasetti Marcela F MF Neuzil Kathleen M KM Laurens Matthew B MB

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases 20210601

<h4>Objectives</h4>In 2017, the World Health Organisation (WHO) pre-qualified a single-dose typhoid conjugate vaccine (TCV) and identified TCV co-administration studies as a research priority. Accordingly, we tested co-administration of Typbar TCV® (Bharat Biotech International) with measles-rubella (MR) and yellow fever (YF) vaccines.<h4>Methods</h4>We conducted a randomized, double-blind, and controlled, phase 2 trial in Ouagadougou, Burkina Faso. Healthy children aged 9-11 months were randomi ...[more]

PMID: 34082090

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Dataset Information

Safety and immunogenicity of Vi-typhoid conjugate vaccine co-administration with routine 9-month vaccination in Burkina Faso: A randomized controlled phase 2 trial.

Objectives

Methods

Results

Conclusion

Publications

Safety and immunogenicity of Vi-typhoid conjugate vaccine co-administration with routine 9-month vaccination in Burkina Faso: A randomized controlled phase 2 trial.

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