Clinical Trial Investigating the Safety and Immunogenicity of GBS6 in Pregnant Women With and Without HIV (PREPARE)

NCT05832502 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 2020.0317
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

A placebo controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human immunodeficiency virus (HIV) infection and their infants

Conditions

Group B Streptococcal Infection

Outcome Measures

Primary Outcomes (6)

• Primary mother outcome 1

  1\. Percentage Occurrence of solicited local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).

  7 days following administration of IMP

• Primary mother outcome 2

  2\. Percentage Occurrence of solicited systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhoea, headache, fatigue/tiredness, muscle pain, and joint pain).

  7 days following administration of IMP

• Primary mother outcome 3

  3\. Percentage Occurrence of solicited and unsolicited adverse events through 1 month after administration of investigational product.

  Through 1 month following administration of IMP

• Primary mother outcome 4

  4\. Number Occurrence of SAEs, MAEs, and obstetric complications (peripartum, intrapartum, and postpartum) throughout the study (Visit 1 through the 12 month postdelivery study visit) and any unsolicited events leading to study withdrawal.

  Visit 1 through 12 months post-delivery

• Primary Infant outcome 1

  1\. Number Occurrence of unsolicited adverse events from birth to 6 weeks of age

  Birth to 6 weeks of age

• Primary Infant outcome 2

  2\. Number Occurrence of SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs through 12 months of age and any unsolicited events leading to study withdrawal.

  Through 12 months of age

Secondary Outcomes (12)

• Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women

  Baseline

• Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women

  2 weeks after vaccination

• Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women

  1 month after vaccination

• Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women

  Delivery

• Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women

  6 weeks after delivery

Other Outcomes (13)

• Mother Exploratory outcome 1 - Ratio Placental transfer ratio of GBS-specific antibodies in HIV-exposed and unexposed pregnancies.

  Baseline through 12 months after delivery

• Mother Exploratory outcome 2 - Percentage Serotype specific GBS positive vaginal and/or rectal culture(s) in HIV positive and HIV negative women.

  Baseline

• Mother Exploratory outcome 2 - Percentage Serotype specific GBS positive vaginal and/or rectal culture(s) in HIV positive and HIV negative women.

  Delivery

Study Arms (4)

Placebo (saline) in HIV-uninfected pregnant woman

PLACEBO COMPARATOR

Placebo (saline control) administered intramuscularly by injecting 0.5 mL into the deltoid muscle

Drug: Placebo

GBS6 in HIV-uninfected pregnant woman

ACTIVE COMPARATOR

GBS6 administered intramuscularly by injecting 0.5 mL into the deltoid muscle

Drug: GBS6

Placebo (saline) in HIV-infected pregnant woman

PLACEBO COMPARATOR

Placebo (saline control) administered intramuscularly by injecting 0.5 mL into the deltoid muscle

Drug: Placebo

GBS6 in HIV-infected pregnant woman

ACTIVE COMPARATOR

GBS6 administered intramuscularly by injecting 0.5 mL into the deltoid muscle

Drug: GBS6

Interventions

GBS6 DRUG

The investigational products are GBS6 and placebo (saline control). The GBS6 dose will be GBS6 20mcg without AlPO4 (equivalent to 240 mcg/mL) 0.5mL dose or 20 mcg CPS/serotype).

Also known as: Hexavalent anti capsular polysaccharide (CPS) / cross reactive material 197 glycoconjugate

GBS6 in HIV-infected pregnant woman; GBS6 in HIV-uninfected pregnant woman

Placebo DRUG

Placebo (saline control) administered intramuscularly by injecting 0.5 mL into the deltoid muscle

Placebo (saline) in HIV-infected pregnant woman; Placebo (saline) in HIV-uninfected pregnant woman

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 to ≤ 40 years of age, inclusive at day of signing the ICF.
• Pregnant at ≥ 27 0/7 to ≤35 6/7 gestation on the day of planned vaccination, verified by ultrasound scan (U/S).
• Low risk, singleton pregnancy, as assessed by the study physician based on ultra-sound scan and previous obstetric history.
• Documented negative HBV surface antigen, HCV antibody, and syphilis tests at screening.
• Documented HIV test during pregnancy undertaken as per the national guidelines.
• If HIV infected pregnant women, stable on ART for at least 3 months prior to study start
• Receiving prenatal standard of care including HIV care if applicable at the clin-ics/physician offices/hospital network affiliated with the clinical study site.
• Willing to give birth at Kawempe Specialised National Referral Hospital, or Kisenyi Health center IV, Uganda.
• Willing and able to participate for the duration of the study visits and follow-up until 12-months post-delivery.
• Willing and able to be contacted by telephone for the full duration of the study, and to give informed consent for their infant participant to participate in the study.
• \. Parent(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures.

You may not qualify if:

• Any of the following:
• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.
• Participants whose unborn baby have been fathered by investigational site staff members directly involved in the conduct of the study or their family members, site staff members otherwise supervised by the investigator, or Pfizer employees directly involved in the conduct of the study.
• Participation in other studies involving investigational drug(s), vaccines, or medical devices within 28 days prior to study entry and/or during study participation.
• Previous vaccination with any licensed or investigational GBS vaccine.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the investigational product.
• History of microbiologically proven invasive disease caused by GBS, or history of an infant with GBS disease.
• Current alcohol abuse or illicit drug use.
• Body mass index (BMI) of ≥40 kg/m2 at the time of the screening visit.
• Clinical history of primary genital herpes simplex virus (HSV) infection during the current pregnancy.
• A prior history of or current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation in, and completion of, the study, including but not limited to the following (refer to the SRM) for further details):
• Gestational hypertension or preeclampsia eclampsia
• Placental abnormality
• Polyhydramnios or oligohydramnios
• Significant bleeding or blood clotting disorder

Sponsors & Collaborators

• St George's, University of London: lead
• MU-JHU CARE: collaborator
• Pfizer: collaborator

Study Sites (1)

Makerere University, John Hopkins University

Kawempe, Uganda

Location

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Musa sekikubo, Prof

  Makerere University - John Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: April 27, 2023
• Study Start: October 14, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 16, 2024

Record last verified: 2023-11

Locations

UG (1)