RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.

NCT02247726 | Completed Phase 2 DMC

• 1 other identifier: RSV-M-203
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess the impact of maternal immunization on infant safety through one year of life.

Conditions

Respiratory Syncytial Virus Infections

Keywords

RSV; Third Trimester; Maternal Immunization

Outcome Measures

Primary Outcomes (9)

• Counts and percentage of subjects with solicited injection site and systemic reactogenicity within seven days of vaccination.

  In Maternal Subjects

  Day 0 to Day D+180

• Counts and percentage of subjects with unsolicited (local and systemic) adverse events (AE), unscheduled medically-attended adverse events (MAEs), and serious adverse events (SAEs) through delivery and six (6) months thereafter.

  In Maternal Subjects

  Day 0 to Day D+180

• Clinical safety laboratory assessments of select serum chemistry and hematology parameters through delivery.

  In Maternal Subjects

  Screening to Day 14

• Counts and percentage of subjects with post-immunization onset of specific complications of third-trimester pregnancy and delivery

  In Maternal Subjects

  Day 0 to Day 28 - 42

• Counts and percentage of term healthy infants appropriate for gestational age.

  In Infant subjects

  Day 28 - 42

• Neonatal SAEs (including congenital anomalies, respiratory failure, fever/infection, and neonatal death or other adverse events/complications that necessitate extended hospitalization).

  In Infant Subjects

  Birth to Day 365

• Growth and development over one year

  In Infant Subjects

  Birth to Day Day 365

• Counts and proportion of infants with unsolicited adverse events

  In Infant Subjects

  Birth to Day 365

• Counts and proportions of infants with medically-attended RSV lower respiratory tract infection (LRTI), and age of onset of those infections.

  In Infant Subjects

  Birth to Day 365

Secondary Outcomes (3)

• Immunogenicity as assessed by serum IgG antibody titers specific fro the F-Protein antigen.

  Birth to Day 180

• Serum antibody titers inhibiting binding of labeled palivizumab to RSV F protein.

  Birth to Day 180

• Serum microneutralization (MN) titers against RSV/A and B.previously referenced, but based on GMT.

  Birth to Day 180

Other Outcomes (3)

• Counts and proportions of maternal subjects with RSV-related respiratory illness as detected by active and passive surveillance.

  Day 0 to Day 180

• Counts and proportions of infants with non-medically attended RSV-related respiratory illness as detected by active and passive surveillance.

  Birth to Day 365

• Counts and proportions of infants with medically attended, non-RSV LRTI as assessed by multiplex real time (RT)-PCR.

  Birth to Day 365

Study Arms (2)

Treatment Group A

PLACEBO COMPARATOR

Saline Placebo (0.5mL injection)

Drug: Saline Placebo (0.5mL injection)

Treatment Group B

EXPERIMENTAL

RSV F vaccine with adjuvant (0.5mL injection)

Drug: RSV F vaccine (0.5mL injection)

Interventions

Saline Placebo (0.5mL injection) DRUG

Also known as: 0.9% Sodium Choloride

Treatment Group A

RSV F vaccine (0.5mL injection) DRUG

Also known as: RSV F Protein with Aluminum adjuvant

Treatment Group B

Eligibility Criteria

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

You may qualify if:

• Pregnant women must meet all of the following criteria to be eligible to participate:
• ≥18 and ≤40 years-of-age.
• Singleton pregnancy of 33 to 35 weeks gestation on the day of planned vaccination.
• Good general maternal health as demonstrated by:
• Medical history (including history of adverse reactions to prior vaccines and allergies).
• Physical examination including at least vital signs (blood pressure, pulse, respirations, and oral temperature); weight; height; examination of the HEENT, cardiovascular, pulmonary, gastrointestinal (abdominal), musculoskeletal, lymphatic, and dermatologic organ systems; and documentation of fetal heart tones.
• Documentation that fulfills one of the following:
• Detailed (level II) second trimester or later anatomic ultrasound with no significant anatomic or growth abnormalities identified; OR
• Routine second trimester or later ultrasound with no significant anatomic or growth abnormalities identified, PLUS at least one of the following:
• Normal first trimester screening (based on ultrasound + serum analytes); or
• Normal cell-free fetal DNA; or
• Normal chorionic villus sampling (CVS) or amniocentesis; or
• Normal second trimester maternal serum quadruple screen; or
• Normal first and second trimester screening using integrated, sequential, or contingency approach; or
• Abnormal first or second trimester screening followed by normal CVS, amniocentesis, or cell-free fetal DNA.

You may not qualify if:

• Pregnant women will be excluded if there is historical, physical examination, or laboratory evidence of any of the following criteria:
• Pre-pregnancy body mass index (BMI) of ≥35 or \<18.5.
• Hemoglobinopathy (including known sickle trait or thalassemias, even if asymptomatic) or blood dyscrasias.
• Hepatic or renal dysfunction.
• Established diagnosis of seizure disorder, regardless of therapy.
• Auto-immune disease or known immunodeficiency syndrome.
• Endocrine disorders, including (but not limited to) hyperthyroidism, untreated hypothyroidism, and glucose intolerance (e.g., diabetes mellitus type 1 or 2) antedating pregnancy, or occurring during pregnancy and requiring interventions other than diet for control.
• History of major gynecologic or major abdominal surgery, including bariatric surgery.
• Known HIV, HBV, or HCV infection, as assessed by serologic tests conducted during the current pregnancy or as a procedure during the screening period of the study.
• Primary genital herpes simplex (HSV) infection during the current pregnancy.
• Current alcohol or drug abuse.
• Documentation that current pregnancy results from fertility treatments, rape, or incest.
• Documentation that the infant will be a ward of the state or be released for adoption.
• Neuro-psychiatric illness deemed likely to interfere with protocol compliance, safety reporting, or receipt of pre-natal care; or requiring treatment with psychotropic drugs.
• History/presence of deep venous thrombosis or thromboembolism, or the use of anticoagulants during pregnancy.

Sponsors & Collaborators

• Novavax: lead

Study Sites (7)

Advanced Specialty Research

Nampa, Idaho, 83687, United States

Location

Hutchinson Clinic, P.A.

Hutchinson, Kansas, 67502, United States

Location

University of Kansas Medical Center Research Institute

Kansas City, Kansas, 66160, United States

Location

Meridian Clinical Research

Norfolk, Nebraska, 68701, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Magee- Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Munoz FM, Swamy GK, Hickman SP, Agrawal S, Piedra PA, Glenn GM, Patel N, August AM, Cho I, Fries L. Safety and Immunogenicity of a Respiratory Syncytial Virus Fusion (F) Protein Nanoparticle Vaccine in Healthy Third-Trimester Pregnant Women and Their Infants. J Infect Dis. 2019 Oct 22;220(11):1802-1815. doi: 10.1093/infdis/jiz390.

  PMID: 31402384 DERIVED

Related Links

• Novavax, Inc.

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Injections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Clinical Development

  Novavax, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

US (7)