To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older

COVID-19 Clinical Trial

Official title:

A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754594
• Other study ID #: C4591015
• Secondary ID: 2020-005444-35
• Status: Completed
• Phase: Phase 3
• Start date: February 16, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: July 2023
• Source: BioNTech SE
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Results will be submitted, however please note that data are not yet available for all serology outcome measures. This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability, and immunogenicity of 30 µg of BNT162b2 or placebo administered in 2 doses, 21 days apart, in approximately 350 healthy pregnant women 18 years of age or older vaccinated at 24 to 34 weeks' gestation. Participants will be randomized 1:1 to receive BNT162b2 or placebo (saline).

Description:

The Phase 2 portion of the study will include approximately 200 pregnant women randomized 1:1 to receive BNT162b2 or placebo (saline) at 27 to 34 weeks' gestation. IRC review of safety data through 7 days after the second dose for all Phase 2 participants will be completed. The Phase 3 portion of this study will assess the safety, tolerability, and immunogenicity of BNT162b2 among pregnant women enrolled at 24 to 34 weeks' gestation. Maternal participants who originally received placebo will receive BNT162b2 at defined time points as part of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 683
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Healthy women =18 years of age who are between 24 0/7 and 34 0/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.

2. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

3. Healthy participants who are determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study

4. Documented negative HIV antibody test (Phase 2 only), syphilis test, and HBV surface antigen test during this pregnancy and prior to randomization

5. Participant is willing to give informed consent for her infant to participate in the study

6. Capable of giving signed informed consent

Exclusion Criteria:

1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

2. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.

3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine.

4. Participants with known or suspected immunodeficiency.

5. Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection.

6. Previous vaccination with any coronavirus vaccine.

7. Receipt of medications intended to prevent COVID 19.

8. Receipt of blood/plasma products or immunoglobulin, from 60 days before administration of study intervention, or planned receipt through delivery, with 1 exception, anti-D immunoglobulin (eg, RhoGAM), which can be given at any time.

9. Current alcohol abuse or illicit drug use.

10. Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt through the postvaccination blood draw.

11. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.

12. Previous participation in other studies involving study intervention containing LNPs.

13. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

14. Participants whose unborn baby has 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.

Related Conditions & MeSH terms

• COVID-19
• Maternal Immunization
• SARS-CoV-2 Infection

Intervention

Biological:
• BNT162b2
Intramuscular Injection

Other:
• Placebo
Intramuscular Injection

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina da Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais
Brazil	Hospital das Clínicas da Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais
Brazil	CEMEC - Centro Multidisciplinar de Estudos Clínicos	São Bernardo do Campo	SÃO Paulo
Brazil	HMU SBC - Hospital Municipal Universitário de São Bernardo	São Bernardo do Campo	SÃO Paulo
Brazil	Clinica de Alergia Martti Antila S/S Ltda./ CMPC - Consultoria Medica e Pesquisa Clinica	Sorocaba	SP
Brazil	Hospital Santa Casa de Misericordia de Sorocaba	Sorocaba	SAO Paulo
Brazil	Unimed Sorocaba-Hospital Dr. Miguel Soeiro (HMS)	Sorocaba	SAO Paulo
South Africa	WorthWhile Clinical Trials	Benoni	Gauteng
South Africa	Dr Tobias de Villiers	Cape Town	Western CAPE
South Africa	Tiervlei Trial Centre CC	Cape Town	Western CAPE
South Africa	Wits Reproductive Health and HIV Institute (Wits RHI) Shandukani Research Centre	Johannesburg	Gauteng
South Africa	Botho Ke Bontle Health Services	Pretoria	Gauteng
South Africa	Vaccines and Infectious Diseases Analytics (VIDA)	Soweto	Gauteng
Spain	Hospital de Antequera	Antequera	Malaga
Spain	Clinica Diagonal	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario HM Monteprincipe	Boadilla del Monte	Madrid
Spain	Hospital Madrid Puerta del Sur Mostoles	Mostoles
Spain	Hospital Materno-Infantil Quirón	Sevilla
Spain	Instituto Hispalense de Pediatria- IHP1	Sevilla
Spain	Servicio de Ginecología del Hospital Quirón Salud Sagrado Corazón	Sevilla
United Kingdom	Medway NHS Foundation Trust	Gillingham	Kent
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	University College London Hospitals	London
United Kingdom	University College London Hospitals	London
United Kingdom	University College London Hospitals	London, City Of
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Hampshire Research Hub, Royal South Hants Hospital	Southampton	Hampshire
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire
United States	Idaho Falls Pediatrics	Ammon	Idaho
United States	Community Hospital of Anaconda	Anaconda	Montana
United States	St. David's Medical Center	Austin	Texas
United States	Tekton Research, Inc.	Austin	Texas
United States	Tekton Research, Inc.	Austin	Texas
United States	Texas Health Harris Methodist Hospital Hurst-Euless-Bedford	Bedford	Texas
United States	Children's of Alabama	Birmingham	Alabama
United States	University of Alabama at Birmingham Women & Infant Center	Birmingham	Alabama
United States	University of Alabama at Birmingham/Center for Women's Reproductive Health	Birmingham	Alabama
United States	Bingham Memorial Hospital	Blackfoot	Idaho
United States	Boeson Research (BUT)	Butte	Montana
United States	SCL St. James Healthcare Hospital	Butte	Montana
United States	Ventavia Research Group LLC	Dallas	Texas
United States	DHR Health Institute for Research and Development	Edinburg	Texas
United States	Allegheny Health and Wellness Pavilion	Erie	Pennsylvania
United States	Central Erie Primary Care	Erie	Pennsylvania
United States	Liberty Family Practice	Erie	Pennsylvania
United States	OBGYN Associates of Erie	Erie	Pennsylvania
United States	Saint Vincent Hospital	Erie	Pennsylvania
United States	8th Avenue Obstetrics & Gynecology	Fort Worth	Texas
United States	Baylor Scott & White All Saints Medical Center	Fort Worth	Texas
United States	Ventavia Research Group, LLC	Fort Worth	Texas
United States	Arrowhead Hospital	Glendale	Arizona
United States	Abrazo West Campus Hospital	Goodyear	Arizona
United States	Marcus Daly Memorial Hospital	Hamilton	Montana
United States	Meridian Clinical Research, LLC	Hastings	Nebraska
United States	Matrix Clinical Research	Huntington Park	California
United States	Matrix Clinical Research.	Huntington Park	California
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Eastern Idaho Regional Medical Center	Idaho Falls	Idaho
United States	Idaho Falls Pediatrics	Idaho Falls	Idaho
United States	Mountain View Hospital	Idaho Falls	Idaho
United States	Chemidox Clinical Trials Inc.	Lancaster	California
United States	East LA Doctors Hospital	Los Angeles	California
United States	Matrix Clinical Research	Los Angeles	California
United States	Axcess Medical Research	Loxahatchee Groves	Florida
United States	Dr. Ruben Aleman & Associates	McAllen	Texas
United States	Boeson Research	Missoula	Montana
United States	Community Medical Center	Missoula	Montana
United States	Community Physicians Group-Maternal Fetal Medicine	Missoula	Montana
United States	Providence St. Patrick Hospital	Missoula	Montana
United States	The Birth Center	Missoula	Montana
United States	Velocity Clinical Research, Gulfport	Mobile	Alabama
United States	Meridian Clinical Research, LLC	Norfolk	Nebraska
United States	The Group for Women- MAWC	Norfolk	Virginia
United States	Tidewater Physicians for Women- MAWC	Norfolk	Virginia
United States	MedPharmics, LLC	Phoenix	Arizona
United States	St. Joseph Hospital	Phoenix	Arizona
United States	Ventavia Research Group, LLC	Plano	Texas
United States	St. Luke Community Healthcare Hospital	Ronan	Montana
United States	Covenant Healthcare	Saginaw	Michigan
United States	Saginaw Valley Medical Research Group, LLC	Saginaw	Michigan
United States	University of Utah	Salt Lake City	Utah
United States	University of Utah Hospital	Salt Lake City	Utah
United States	Ventavia Research Group, LLC	Weatherford	Texas
United States	Weatherford OBGYN	Weatherford	Texas

Sponsors (2)

Lead Sponsor	Collaborator
BioNTech SE	Pfizer

Countries where clinical trial is conducted

United States,  Brazil,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of maternal participants reporting: Local reactions	Pain at the injection site, redness, and swelling as self-reported on electronic diaries	For 7 Days after Dose 1 and Dose 2
Primary	Percentage of maternal participants reporting systemic events	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.	For 7 days after Dose 1 and Dose 2
Primary	Percentage of maternal participants reporting adverse events	As elicited by investigational site staff	From Dose 1 through 1 month after Dose 2
Primary	Percentage of maternal participants reporting serious adverse events	As elicited by investigational site staff	From Dose 1 through 6 months after delivery
Primary	Describe the immune response in pregnant women and reference to the immune response to nonpregnant female participants from the C4591001 study without evidence of past SARS-CoV-2 infection.	GMR, estimated by the ratio of the geometric mean of SARS CoV 2 neutralizing titers in pregnant women to those in nonpregnant female participants	1 month after Dose 2
Primary	Describe the immune response in pregnant women and reference to the immune response in nonpregnant female participants from the C4591001 study with and without evidence of prior SARS-CoV-2 infection	GMR, estimated by the ratio of the geometric mean of SARS CoV 2 neutralizing titers in pregnant women to those in nonpregnant female participants	1 month after Dose 2
Secondary	Confirmed COVID 19 in participants without evidence of infection prior to vaccination	1000 person years of follow-up	7 days after Dose 2 through 1 month after delivery
Secondary	Confirmed COVID 19 in participants with and without evidence of infection prior to vaccination	1000 person years of follow-up	7 days after Dose 2 through 1 month after delivery
Secondary	Describe the efficacy of prophylactic BNT162b2 against asymptomatic SARS-CoV-2 infection without evidence of prior SARS-CoV-2 infection	Incidence of asymptomatic infection of SARS-CoV-2 based on N-binding antibody seroconversion	1 month after delivery
Secondary	Describe the immune response over time and persistence of prophylactic BNT162b2	GMCs/GMTs and GMFRs of Full-length S-binding IgG levels and SARS-CoV-2 neutralizing titers	At baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
Secondary	Assess the safety of maternal immunization in infants born to maternal participants who were vaccinated with BNT162b2 during pregnancy	Specific birth outcomes (infant outcome using percentage of births clinically assessed as either normal, congenital malformation/anomaly or other neonatal problem as reported by the investigator)	At birth
Secondary	Assess the safety of maternal immunization in infants born to maternal participants who were vaccinated with BNT162b2 during pregnancy	AEs	From birth through 1 month of age
Secondary	Assess the safety of maternal immunization in infants born to maternal participants who were vaccinated with BNT162b2 during pregnancy	SAEs and AESIs (major congenital anomalies, developmental delay)	Through 6 months of age
Secondary	Describe the immune response in infants born to maternal participants vaccinated with prophylactic BNT162b2 during pregnancy	GMCs and GMFRs of Full-length S-binding IgG levels	At birth and 6 months after delivery

External Links

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