Group B Streptococcus Vaccine for Healthy Subjects

Recruiting at 42 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Disqualifiers: BMI >40, Pregnancy complications, Infections, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

6000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vaccine for group B streptococcus (GBS) to determine its safety and effectiveness for pregnant women and their babies. GBS can cause serious infections in newborns, so the vaccine aims to protect them. Pregnant women between 24 and 36 weeks who are healthy, have had normal ultrasounds, and test negative for HIV, syphilis, and Hepatitis B might be suitable candidates. Participants will receive one injection, which could be the actual vaccine or a placebo (a harmless saline solution). The trial involves several visits and follows participants for up to 14 months after delivery. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking vaccine.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study contact or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that the multivalent Group B streptococcus vaccine (GBS6) is well tolerated. Research indicates that the vaccine is safe, with no deaths or serious side effects linked to it. Minor issues, such as belly button hernias, were the most common side effects in infants, but these were not directly related to the vaccine. Additionally, a booster dose of the vaccine in non-pregnant adults led to strong immune responses without major safety concerns.

Commercial vaccines like Infanrix hexa, Infanrix, Prevnar 20, and Pediarix are already approved and widely used for other conditions. These vaccines generally have well-established safety records, providing reassurance about their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the multivalent Group B streptococcus (GBS) vaccine, known as GBS6, because it targets multiple strains of the bacteria responsible for GBS infections, offering broader protection than existing vaccines. Unlike standard treatments, which typically address a single strain, GBS6 is designed to prevent infections from multiple strains simultaneously. This approach not only enhances the effectiveness of the vaccine but also improves its potential to reduce the incidence of GBS-related complications in healthy individuals.

What evidence suggests that this trial's treatments could be effective for group B streptococcus?

Research shows that the GBS6 vaccine, a treatment in this trial, targets Group B streptococcus (GBS) and holds promise in preventing GBS infections. Studies indicate that an effective GBS vaccine could significantly reduce infections in both mothers and their babies. Evidence suggests that GBS6 may offer strong protection against serious GBS disease in newborns and young infants. The vaccine is designed for pregnant women to help protect their babies from GBS after birth. Earlier studies demonstrated that the vaccine is safe and can trigger a strong immune response, with few side effects reported. ^{1 2 3 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

The BEATRIX trial is for healthy pregnant women under 50, between 24-36 weeks along, with a normal fetal ultrasound and negative tests for HIV, syphilis, and Hepatitis B. Participants will be involved in the study up to 14 months post-delivery; their babies may participate for about 12 months.

Inclusion Criteria

Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed

Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization

Willing to give informed consent for her infant to participate in the study

Exclusion Criteria

Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study

Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study

Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pregnant participants receive one shot of either the GBS6 vaccine or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with visits occurring up to 6 months after delivery

14 months

3-4 visits (in-person/telephone)

Infant Follow-up

Infants are monitored for safety and effectiveness, with a subset participating for up to 19 months

12-19 months

What Are the Treatments Tested in This Trial?

Interventions

• Multivalent Group B streptococcus vaccine

Trial Overview This study tests the safety and effectiveness of a Group B streptococcus vaccine (GBS6) versus placebo in pregnant women and their infants. A subset of infants will also receive standard vaccines like diphtheria toxoid-containing vaccine or pneumococcal vaccine as part of their regular immunization schedule.

How Is the Trial Designed?

Group I: Prevnar 20 Experimental Treatment 1 Intervention

Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae

Group II: Prevenar 20 Experimental Treatment 1 Intervention

Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae

Group III: Pediarix Experimental Treatment 1 Intervention

Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio

Group IV: Infanrix hexa Experimental Treatment 1 Intervention

Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib)

Group V: Infanrix Experimental Treatment 1 Intervention

Commercially available combination vaccine containing diphtheria, tetanus, and pertussis

Group VI: GBS6 Experimental Treatment 1 Intervention

Multivalent group B streptococcus vaccine

Group VII: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7196769/

A Vaccine Against Group B Streptococcus: Recent Advances Recent estimates suggest that an effective GBS maternal vaccine (>80% efficacy), with high (90%) global coverage, could prevent 231,000 infant and maternal GBS ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2116045

Potential for Maternally Administered Vaccine for Infant ... Such a vaccine could be beneficial because intrapartum antibiotic prophylaxis may contribute to antimicrobial resistance and disrupt development ...

3. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(25)00216-6/abstract

Safety and immunogenicity of a booster dose of a novel ... Low rates of medically attended adverse events were reported in both groups of participants receiving a booster dose of GBS6 (nine [12%] of 76 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03765073

Study Details | NCT03765073 | Trial To Evaluate The ... Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent ...

5. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer-announces-new-england-journal-medicine-publication

Pfizer Announces New England Journal of Medicine ... The Phase 2 study immunogenicity data suggest that GBS6 may offer meaningful protection against invasive GBS disease in newborns and young infants.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10005905/

Safety and immunogenicity of the group B streptococcus ... The vaccine was well tolerated and had a good safety profile. There were no deaths and no serious adverse events (AEs) considered related to ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473309925002166

Safety and immunogenicity of a booster dose of a novel ... A booster dose of GBS6 elicited robust GBS serotype-specific anti-CPS IgG responses that were two-fold to 18-fold higher 1 month after the booster dose.