Trial Outcomes & Findings for 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 (NCT NCT03049488)

Last Updated: 2020-10-23

Results Overview

Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

95 participants

Primary outcome timeframe

7 days after the first product administration (Day 7)

Results posted on

2020-10-23

Participant Flow

Healthy adults were recruited from the Washington, D.C., metropolitan area.

Participant milestones

Participant milestones
Measure	Group 1: DS-Cav1 (50 mcg) DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 3: DS-Cav1 (150 mcg) DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 4: DS-Cav1 (150 mcg) + Alum DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 6: DS-Cav1 (500 mcg) + Alum DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
Overall Study STARTED	15	15	20	15	15	15
Overall Study Received First Product Administration	15	15	20	15	15	15
Overall Study Received Optional Second Dose	10	11	11	9	11	10
Overall Study COMPLETED	13	13	20	13	13	15
Overall Study NOT COMPLETED	2	2	0	2	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: DS-Cav1 (50 mcg) DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 4: DS-Cav1 (150 mcg) + Alum DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.
Overall Study Lost to Follow-up	1	1	0	0
Overall Study Moved from Area	1	0	1	1
Overall Study Physician Decision	0	1	0	0
Overall Study Withdrawal by Subject	0	0	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: DS-Cav1 (50 mcg) n=15 Participants DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum n=15 Participants DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 3: DS-Cav1 (150 mcg) n=20 Participants DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 4: DS-Cav1 (150 mcg) + Alum n=15 Participants DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) n=15 Participants DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 6: DS-Cav1 (500 mcg) + Alum n=15 Participants DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Total n=95 Participants Total of all reporting groups
Age, Customized 18-20 years	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants
Age, Customized 21-30 years	4 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	6 Participants n=4 Participants	8 Participants n=21 Participants	11 Participants n=10 Participants	42 Participants n=115 Participants
Age, Customized 31-40 years	9 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=10 Participants	33 Participants n=115 Participants
Age, Customized 41-50 years	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=10 Participants	16 Participants n=115 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=21 Participants	8 Participants n=10 Participants	49 Participants n=115 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	7 Participants n=10 Participants	46 Participants n=115 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	15 Participants n=115 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	9 Participants n=115 Participants
Race/Ethnicity, Customized White	10 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	9 Participants n=4 Participants	12 Participants n=21 Participants	10 Participants n=10 Participants	65 Participants n=115 Participants
Race/Ethnicity, Customized Multiracial	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	6 Participants n=115 Participants
Race/Ethnicity, Customized Hispanic/Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=10 Participants	8 Participants n=115 Participants
Body Mass Index (BMI) 18.5-24.9 kg/m^2	5 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants	8 Participants n=10 Participants	39 Participants n=115 Participants
Body Mass Index (BMI) 25.0-29.9 kg/m^2	8 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	7 Participants n=21 Participants	5 Participants n=10 Participants	39 Participants n=115 Participants
Body Mass Index (BMI) 30.0 kg/m^2 or over	2 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	17 Participants n=115 Participants

PRIMARY outcome

Timeframe: 7 days after the first product administration (Day 7)

Population: Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).

Outcome measures

Outcome measures
Measure	Group 1: DS-Cav1 (50 mcg) n=15 Participants DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum n=15 Participants DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 3: DS-Cav1 (150 mcg) n=20 Participants DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 4: DS-Cav1 (150 mcg) + Alum n=15 Participants DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) n=15 Participants DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 6: DS-Cav1 (500 mcg) + Alum n=15 Participants DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	All DS-Cav1 Dose Groups DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
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 Pain/Tenderness · None	6 Participants	5 Participants	11 Participants	8 Participants	7 Participants	6 Participants	—
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 Pain/Tenderness · Mild	9 Participants	10 Participants	9 Participants	7 Participants	8 Participants	9 Participants	—
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 Pain/Tenderness · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Pain/Tenderness · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Swelling · None	15 Participants	15 Participants	20 Participants	15 Participants	15 Participants	14 Participants	—
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 Swelling · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—
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 Swelling · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Swelling · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Redness · None	15 Participants	15 Participants	20 Participants	15 Participants	15 Participants	15 Participants	—
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 Redness · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Redness · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Redness · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Any Local Symptom · None	6 Participants	5 Participants	11 Participants	8 Participants	7 Participants	6 Participants	—
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 Any Local Symptom · Mild	9 Participants	10 Participants	9 Participants	7 Participants	8 Participants	9 Participants	—
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 Any Local Symptom · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Any Local Symptom · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: 7 days after the second product administration (Day 91)

Population: Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=62).

Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

Outcome measures

Outcome measures
Measure	Group 1: DS-Cav1 (50 mcg) n=10 Participants DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum n=11 Participants DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 3: DS-Cav1 (150 mcg) n=11 Participants DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 4: DS-Cav1 (150 mcg) + Alum n=9 Participants DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) n=11 Participants DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 6: DS-Cav1 (500 mcg) + Alum n=10 Participants DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	All DS-Cav1 Dose Groups DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
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 Redness · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Redness · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Any Local Symptom · None	3 Participants	6 Participants	6 Participants	4 Participants	2 Participants	3 Participants	—
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 Any Local Symptom · Mild	7 Participants	5 Participants	5 Participants	5 Participants	8 Participants	7 Participants	—
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 Any Local Symptom · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—
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 Any Local Symptom · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Pain/Tenderness · None	3 Participants	6 Participants	6 Participants	4 Participants	2 Participants	3 Participants	—
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 Pain/Tenderness · Mild	7 Participants	5 Participants	5 Participants	5 Participants	8 Participants	7 Participants	—
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 Pain/Tenderness · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—
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 Pain/Tenderness · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Swelling · None	10 Participants	11 Participants	11 Participants	9 Participants	11 Participants	10 Participants	—
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 Swelling · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Swelling · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Swelling · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Redness · None	10 Participants	11 Participants	11 Participants	9 Participants	11 Participants	10 Participants	—
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 Redness · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: 7 days after each product administration

Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

Outcome measures

Outcome measures
Measure	Group 1: DS-Cav1 (50 mcg) n=15 Participants DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum n=15 Participants DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 3: DS-Cav1 (150 mcg) n=20 Participants DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 4: DS-Cav1 (150 mcg) + Alum n=15 Participants DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) n=15 Participants DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 6: DS-Cav1 (500 mcg) + Alum n=15 Participants DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	All DS-Cav1 Dose Groups n=95 Participants DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Redness · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Redness · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Redness · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Any Local Symptom · None	4 Participants	5 Participants	8 Participants	3 Participants	4 Participants	3 Participants	27 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Any Local Symptom · Mild	11 Participants	10 Participants	12 Participants	12 Participants	10 Participants	12 Participants	67 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Any Local Symptom · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Any Local Symptom · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Pain/Tenderness · None	4 Participants	5 Participants	8 Participants	3 Participants	4 Participants	3 Participants	27 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Pain/Tenderness · Mild	11 Participants	10 Participants	12 Participants	12 Participants	10 Participants	12 Participants	67 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Pain/Tenderness · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Pain/Tenderness · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Swelling · None	15 Participants	15 Participants	20 Participants	15 Participants	15 Participants	14 Participants	94 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Swelling · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Swelling · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Swelling · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Redness · None	15 Participants	15 Participants	20 Participants	15 Participants	15 Participants	15 Participants	95 Participants

PRIMARY outcome

Timeframe: 7 days after the first product administration (Day 7)

Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

Outcome measures

Outcome measures
Measure	Group 1: DS-Cav1 (50 mcg) n=15 Participants DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum n=15 Participants DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 3: DS-Cav1 (150 mcg) n=20 Participants DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 4: DS-Cav1 (150 mcg) + Alum n=15 Participants DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) n=15 Participants DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 6: DS-Cav1 (500 mcg) + Alum n=15 Participants DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	All DS-Cav1 Dose Groups DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
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 Malaise · None	13 Participants	13 Participants	17 Participants	12 Participants	11 Participants	11 Participants	—
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 Malaise · Mild	2 Participants	2 Participants	3 Participants	3 Participants	4 Participants	4 Participants	—
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 Malaise · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Chills · None	14 Participants	15 Participants	20 Participants	14 Participants	13 Participants	13 Participants	—
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 Malaise · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Myalgia · None	15 Participants	13 Participants	19 Participants	9 Participants	12 Participants	13 Participants	—
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 Myalgia · Mild	0 Participants	2 Participants	1 Participants	6 Participants	3 Participants	2 Participants	—
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 Myalgia · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Myalgia · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Headache · None	13 Participants	11 Participants	18 Participants	10 Participants	13 Participants	10 Participants	—
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 Headache · Mild	2 Participants	4 Participants	2 Participants	5 Participants	2 Participants	5 Participants	—
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 Headache · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Headache · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Chills · Mild	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	2 Participants	—
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 Chills · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Chills · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Nausea · None	14 Participants	14 Participants	19 Participants	15 Participants	14 Participants	14 Participants	—
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 Nausea · Mild	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	—
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 Nausea · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Nausea · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Temperature · None	15 Participants	15 Participants	20 Participants	15 Participants	14 Participants	15 Participants	—
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 Temperature · Mild	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—
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 Temperature · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Temperature · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Any Systemic Symptom · None	12 Participants	11 Participants	15 Participants	9 Participants	10 Participants	9 Participants	—
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 Any Systemic Symptom · Mild	3 Participants	4 Participants	5 Participants	6 Participants	5 Participants	6 Participants	—
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 Any Systemic Symptom · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Any Systemic Symptom · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: 7 days after the second product administration (Day 91)

Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

Outcome measures

Outcome measures
Measure	Group 1: DS-Cav1 (50 mcg) n=10 Participants DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum n=11 Participants DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 3: DS-Cav1 (150 mcg) n=11 Participants DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 4: DS-Cav1 (150 mcg) + Alum n=9 Participants DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) n=11 Participants DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 6: DS-Cav1 (500 mcg) + Alum n=10 Participants DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	All DS-Cav1 Dose Groups DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
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 Malaise · None	9 Participants	9 Participants	11 Participants	8 Participants	8 Participants	9 Participants	—
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 Malaise · Mild	0 Participants	2 Participants	0 Participants	1 Participants	3 Participants	1 Participants	—
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 Malaise · Moderate	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Malaise · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Myalgia · None	9 Participants	10 Participants	9 Participants	8 Participants	10 Participants	7 Participants	—
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 Myalgia · Mild	1 Participants	1 Participants	2 Participants	1 Participants	1 Participants	3 Participants	—
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 Myalgia · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Myalgia · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Headache · None	8 Participants	10 Participants	10 Participants	8 Participants	8 Participants	9 Participants	—
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 Headache · Mild	2 Participants	1 Participants	1 Participants	1 Participants	2 Participants	1 Participants	—
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 Headache · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—
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 Headache · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Chills · None	10 Participants	11 Participants	11 Participants	9 Participants	11 Participants	9 Participants	—
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 Chills · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—
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 Chills · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Chills · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Nausea · None	10 Participants	11 Participants	11 Participants	9 Participants	11 Participants	9 Participants	—
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 Nausea · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—
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 Nausea · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Nausea · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Temperature · None	10 Participants	11 Participants	11 Participants	9 Participants	11 Participants	9 Participants	—
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 Temperature · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—
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 Temperature · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Temperature · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
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 Any Systemic Symptom · None	7 Participants	9 Participants	9 Participants	7 Participants	7 Participants	6 Participants	—
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 Any Systemic Symptom · Mild	2 Participants	2 Participants	2 Participants	2 Participants	3 Participants	4 Participants	—
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 Any Systemic Symptom · Moderate	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—
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 Any Systemic Symptom · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: 7 days after each product administration

Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

Outcome measures

Outcome measures
Measure	Group 1: DS-Cav1 (50 mcg) n=15 Participants DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum n=15 Participants DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 3: DS-Cav1 (150 mcg) n=20 Participants DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 4: DS-Cav1 (150 mcg) + Alum n=15 Participants DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) n=15 Participants DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 6: DS-Cav1 (500 mcg) + Alum n=15 Participants DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	All DS-Cav1 Dose Groups n=95 Participants DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Temperature · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Malaise · None	12 Participants	11 Participants	17 Participants	12 Participants	9 Participants	11 Participants	72 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Malaise · Mild	2 Participants	4 Participants	3 Participants	3 Participants	6 Participants	4 Participants	22 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Malaise · Moderate	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Malaise · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Myalgia · None	14 Participants	12 Participants	17 Participants	9 Participants	12 Participants	12 Participants	76 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Myalgia · Mild	1 Participants	3 Participants	3 Participants	6 Participants	3 Participants	3 Participants	19 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Myalgia · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Myalgia · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Headache · None	12 Participants	10 Participants	17 Participants	9 Participants	11 Participants	10 Participants	69 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Headache · Mild	3 Participants	5 Participants	3 Participants	6 Participants	3 Participants	5 Participants	25 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Headache · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Headache · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Chills · None	14 Participants	15 Participants	20 Participants	14 Participants	13 Participants	13 Participants	89 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Chills · Mild	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	2 Participants	6 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Chills · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Chills · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Nausea · None	14 Participants	14 Participants	19 Participants	15 Participants	14 Participants	13 Participants	89 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Nausea · Mild	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	6 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Nausea · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Nausea · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Temperature · None	15 Participants	15 Participants	20 Participants	15 Participants	14 Participants	14 Participants	93 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Temperature · Mild	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Temperature · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Any Systemic Symptom · None	10 Participants	10 Participants	13 Participants	8 Participants	8 Participants	7 Participants	56 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Any Systemic Symptom · Mild	4 Participants	5 Participants	7 Participants	7 Participants	6 Participants	8 Participants	37 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Any Systemic Symptom · Moderate	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant Any Systemic Symptom · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0 through Day 308

Population: Population included all enrolled subjects who had laboratory results available at any study visit post baseline.

Any abnormal laboratory results recorded as unsolicited AEs are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, white blood cell (WBC) and red blood cell (RBC) counts, and neutrophil, lymphocyte, monocyte, eosinophil and basophil percents and counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) differential, platelet, creatinine and ALT results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), and at Days 7, 28, 84, 91 and 112. Institutional laboratory normals as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.

Outcome measures

Outcome measures
Measure	Group 1: DS-Cav1 (50 mcg) n=15 Participants DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum n=15 Participants DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 3: DS-Cav1 (150 mcg) n=20 Participants DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 4: DS-Cav1 (150 mcg) + Alum n=15 Participants DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) n=15 Participants DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 6: DS-Cav1 (500 mcg) + Alum n=15 Participants DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	All DS-Cav1 Dose Groups n=95 Participants DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
Number of Subjects With Abnormal Laboratory Measures of Safety Eosinophil Count	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Measures of Safety ALT	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Laboratory Measures of Safety Creatinine	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Measures of Safety WBC Count	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Laboratory Measures of Safety Hemoglobin	3 Participants	0 Participants	1 Participants	1 Participants	4 Participants	1 Participants	10 Participants
Number of Subjects With Abnormal Laboratory Measures of Safety Neutrophil Count	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants	1 Participants	6 Participants
Number of Subjects With Abnormal Laboratory Measures of Safety Lymphocyte Count	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 0 through Day 28 after product administration

Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 28 days after each study product administration. At other time periods between study product administrations and when greater than 28 days after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity.

Outcome measures

Outcome measures
Measure	Group 1: DS-Cav1 (50 mcg) n=15 Participants DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum n=15 Participants DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 3: DS-Cav1 (150 mcg) n=20 Participants DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 4: DS-Cav1 (150 mcg) + Alum n=15 Participants DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) n=15 Participants DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 6: DS-Cav1 (500 mcg) + Alum n=15 Participants DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	All DS-Cav1 Dose Groups DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) Related to Study Product	3 Participants	3 Participants	2 Participants	0 Participants	4 Participants	3 Participants	—
Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) Unrelated to Study Product	3 Participants	7 Participants	12 Participants	7 Participants	7 Participants	6 Participants	—

PRIMARY outcome

Timeframe: Day 0 through Day 308

SAEs were reported from receipt of first study product administration through the last expected study visit at Day 308. The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity.

Outcome measures

Outcome measures
Measure	Group 1: DS-Cav1 (50 mcg) n=15 Participants DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum n=15 Participants DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 3: DS-Cav1 (150 mcg) n=20 Participants DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 4: DS-Cav1 (150 mcg) + Alum n=15 Participants DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) n=15 Participants DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 6: DS-Cav1 (500 mcg) + Alum n=15 Participants DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	All DS-Cav1 Dose Groups DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
Number of Subjects With Serious Adverse Events (SAEs) Related to Study Product	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Serious Adverse Events (SAEs) Unrelated to Study Product	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Day 0 through Day 308

Population: Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant (N=95).

Respiratory Syncytial Virus (RSV) cases were recorded in the study database from receipt of the first study product administration through the last study visit.

Outcome measures

Outcome measures
Measure	Group 1: DS-Cav1 (50 mcg) n=15 Participants DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum n=15 Participants DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 3: DS-Cav1 (150 mcg) n=20 Participants DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 4: DS-Cav1 (150 mcg) + Alum n=15 Participants DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) n=15 Participants DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 6: DS-Cav1 (500 mcg) + Alum n=15 Participants DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	All DS-Cav1 Dose Groups DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: 4 weeks after the first product administration (Week 4)

Population: Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant (N=95).

Neutralizing antibody titers were determined against a reporter RSV A2 virus (RSV A), and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. Measurements were normalized to international units per milliliter.

Outcome measures

Outcome measures
Measure	Group 1: DS-Cav1 (50 mcg) n=15 Participants DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 2: DS-Cav1 (50 mcg) + Alum n=15 Participants DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 3: DS-Cav1 (150 mcg) n=20 Participants DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 4: DS-Cav1 (150 mcg) + Alum n=15 Participants DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Group 5: DS-Cav1 (500 mcg) n=15 Participants DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	Group 6: DS-Cav1 (500 mcg) + Alum n=15 Participants DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12\) \To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	All DS-Cav1 Dose Groups DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
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 Week 0 (Baseline, Pre-Administration)	777 titer Interval 192.0 to 3167.0	689 titer Interval 288.0 to 2141.0	736 titer Interval 216.0 to 4676.0	653 titer Interval 186.0 to 2476.0	707 titer Interval 230.0 to 5725.0	669 titer Interval 321.0 to 1840.0	—
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 Week 4	4203 titer Interval 1001.0 to 10910.0	3486 titer Interval 1385.0 to 18852.0	5422 titer Interval 2050.0 to 13104.0	5513 titer Interval 1715.0 to 17602.0	7495 titer Interval 2370.0 to 16870.0	6083 titer Interval 2301.0 to 13522.0	—

SECONDARY outcome

Timeframe: 4 weeks after the second product administration (Week 16)

Population: Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant (N=62).