Phase 1 N=95 Randomized Prevention

Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults

Respiratory Syncytial Virus

Bottom Line

View on ClinicalTrials.gov: NCT03049488 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant — 6; 5; 11; 8 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: VRC-RSVRGP084-00-VP (Biological); Aluminum Hydroxide Suspension (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant	6; 5; 11; 8; 7; 6	—
PRIMARY Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant	3; 6; 6; 4; 2; 3	—
PRIMARY Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant	4; 5; 8; 3; 4; 3	—
PRIMARY Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant	13; 13; 17; 12; 11; 11	—
PRIMARY Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant	9; 9; 11; 8; 8; 9	—
PRIMARY Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant	12; 11; 17; 12; 9; 11	—
PRIMARY Number of Subjects With Abnormal Laboratory Measures of Safety	0; 1; 1; 1; 0; 0	—
PRIMARY Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs)	3; 3; 2; 0; 4; 3	—
PRIMARY Number of Subjects With Serious Adverse Events (SAEs)	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration	1; 0; 0; 0; 0; 0	—
SECONDARY Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant	777; 689; 736; 653; 707; 669	—
SECONDARY Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant	866; 734; 790; 578; 680; 839	—

Summary

Background: Respiratory Syncytial Virus (RSV) is a virus that infects the lungs and breathing passages. Healthy adults who are infected generally have mild cold symptoms for a week or two. But it can also be serious, especially for infants and older adults. It can be spread by direct or indirect contact with respiratory secretions. Researchers want to study a new vaccine to prevent RSV. Objective: To see if a vaccine for RSV is safe and if it causes side effects. Eligibility: Healthy adults 18-50 years old Design: Volunteers were screened in a separate screening protocol. Subjects had 13 visits over 1 year. Some subjects received just vaccine. Some received vaccine mixed with alum adjuvant. All subjects received their dose by injection in the upper arm. They received up to two doses, one at the beginning of the study and another 12 weeks later. Subjects were monitored for 1 hour after injection and called to check on their safety 1 day after. Subjects recorded their temperature and side effects for 7 days after each vaccination. Subjects were provided with a thermometer to measure their temperature and a ruler to measure any changes if these occurred on their skin at the injection site. At all visits, subjects were checked for health changes or problems. They may have had blood drawn. At some visits, subjects had samples collected from their nose and mouth.

Eligibility Criteria

INCLUSION CRITERIA:
18 to 50 years of age.
Willing and able to complete the informed consent process.
Available for clinic visits through 44 weeks after enrollment.
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
Willing to donate blood and mucosal samples to be stored and used for future research.
In good general health without clinically significant medical history.
Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 56 days prior to enrollment. Laboratory criteria within 56 days prior to enrollment:
White Blood Cell (WBC) and differential either within institutional normal range or accompanied by Principal Investigator (PI) or designee approval.
Platelets = 125,000-500,000/mm^3.
Hemoglobin within institutional normal range.
Creatinine less than or equal to 1.1 x upper limit of normal (ULN).
Alanine aminotransferase (ALT) less than or equal to 1.25 x ULN.
Negative for HIV infection by an FDA approved method of detection.

Criteria applicable to women of childbearing potential:

Negative result on a human chorionic gonadotropin pregnancy test on day of enrollment before receiving study product.
Agree to use effective means of birth control from at least 21 days before enrollment through 4 weeks after the last injection.
EXCLUSION CRITERIA:

Criteria applicable to women of childbearing potential:

Breast-feeding or planning to become pregnant through 4 weeks after the last injection.

Subject has received any of the following:

More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment.
Blood products within 16 weeks prior to enrollment.
Live attenuated vaccines within 4 weeks prior to enrollment.
Inactivated vaccines within 2 weeks prior to enrollment.
Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study.
Current allergen immunotherapy with antigen injections, unless on maintenance schedule.
Current anti-tuberculosis(TB) prophylaxis or therapy.

Subject has any of the following:

Serious reactions to vaccines that preclude receipt of study injections as determined by the investigator.
Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
Asthma that is not well controlled.
Diabetes mellitus (type I or II), with the exception of gestational diabetes.
Thyroid disease that is not well controlled.
Hypertension that is not well controlled.
Evidence of autoimmune disease or immunodeficiency.
Idiopathic urticaria within the past year.
Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
Malignancy that is active or history of malignancy that is likely to recur during the study.
Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years.
Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within 5 years prior to enrollment, a history of suicide plan or attempt.
Any medical, psychiatric, or social condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject s ability to give informed consent.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03049488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.