Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age

Summary

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.

Timeline

Start

2010-10

Primary completion

2011-12

Completion

2012-12

Outcome

Met primary endpoint

paper For cohort 2, pregnant women in all vaccine groups had significantly higher GMCs than did those in the placebo group at delivery PMID 27139805 ↗

paper The vaccine was well tolerated and induced capsular-specific antibody responses, in non-pregnant and pregnant women. PMID 27139805 ↗

Publications

• Madhi SA, Koen A, Cutland CL, Jose L, Govender N, Wittke F, Olugbosi M, Sobanjo-Ter Meulen A, Baker S, Dull PM, Narasimhan V, Slobod K. Antibody Kinetics and Response to Routine Vaccinations in Infants Born to Women Who Received an Investigational Trivalent Group B Streptococcus Polysaccharide CRM197-Conjugate Vaccine During Pregnancy. Clin Infect Dis. 2017 Nov 13;65(11):1897-1904. doi: 10.1093/cid/cix666.
• Madhi SA, Cutland CL, Jose L, Koen A, Govender N, Wittke F, Olugbosi M, Meulen AS, Baker S, Dull PM, Narasimhan V, Slobod K. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in healthy women and their infants: a randomised phase 1b/2 trial. Lancet Infect Dis. 2016 Aug;16(8):923-34. doi: 10.1016/S1473-3099(16)00152-3. Epub 2016 Apr 29.
• Cutland CL, Cunnington M, Olugbosi M, Jones SA, Hugo A, Maharaj K, Slobod K, Madhi SA. Lessons learnt from enrolment and follow up of pregnant women and their infants in clinical trials in South Africa, a low-middle income country. Vaccine. 2015 Nov 25;33(47):6406-12. doi: 10.1016/j.vaccine.2015.08.040. Epub 2015 Sep 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Group B Streptococcus Trivalent Vaccine	Vaccine	0.5 ug	Other
Subject	Group B Streptococcus Trivalent Vaccine	Vaccine	2.5 ug	Other
Subject	Group B Streptococcus Trivalent Vaccine	Vaccine	5 ug	Other
Subject	Group B Streptococcus Trivalent Vaccine	Vaccine	20 ug	Other

Indications