Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04596878
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2020-10-14
Brief Title:
Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV
Sponsor:
Minervax ApS
Organization:
Minervax ApS
Study Overview
Official Title:
A Multi-centre Study to Evaluate the Safety Tolerability and Immunogenicity of Two Doses of a Group B Streptococcus Vaccine GBS-NNNN2 in Women Who Are Pregnant and Living With HIV and Women Who Are Pregnant and do Not Have HIV
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomised placebo-controlled double-blind study to evaluate the safety tolerability and immunogenicity of the GBS-NNNN2 Recombinant protein vaccine against Group B Streptococcus vaccine in women living with HIV and women without HIVand their newborn babies from vaccination up to deliverybirth Mothers and babies will be followed up for 6 months post-delivery
Detailed Description:
100 women who are pregnant and living with HIV will randomly receive two 05 mL millilitre intramuscular injections of GBS-NNNN2 vaccine 60 women or placebo 15 women
100 women who are pregnant and do not have HIV will randomly receive two 05 mL intramuscular injections of GBS-NNNN2 vaccine 60 women or placebo 15 women
Participants will be screened at 24 to 28 weeks gestation Days -14 to Day -1 and the groups will be dosed in parallel The first dose of vaccine or placebo will be administered at Day 0 and the second dose will be administered 282 days later Delivery is anticipated to be approximately 10 to 14 weeks after the first dose of vaccine
For the analysis of the immune response the placebo groups will be combined For safety the placebo groups will be analysed separately and will be combined for comparison with the potential vaccine groups
100 women who are pregnant and do not have HIV will randomly receive two 05 mL intramuscular injections of GBS-NNNN2 vaccine 60 women or placebo 15 women
Participants will be screened at 24 to 28 weeks gestation Days -14 to Day -1 and the groups will be dosed in parallel The first dose of vaccine or placebo will be administered at Day 0 and the second dose will be administered 282 days later Delivery is anticipated to be approximately 10 to 14 weeks after the first dose of vaccine
For the analysis of the immune response the placebo groups will be combined For safety the placebo groups will be analysed separately and will be combined for comparison with the potential vaccine groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None