Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: VRC 317: A Phase I Randomized, Open-Label Clinical Trial to Evaluate 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
Brief Summary: Background:

Respiratory Syncytial Virus (RSV) is a virus that infects the lungs and breathing passages. Healthy adults who are infected generally have mild cold symptoms for a week or two. But it can also be serious, especially for infants and older adults. It can be spread by direct or indirect contact with respiratory secretions. Researchers want to study a new vaccine to prevent RSV.

Objective:

To see if a vaccine for RSV is safe and if it causes side effects.

Eligibility:

Healthy adults 18-50 years old

Design:

Volunteers were screened in a separate screening protocol.

Subjects had 13 visits over 1 year.

Some subjects received just vaccine. Some received vaccine mixed with alum adjuvant.

All subjects received their dose by injection in the upper arm. They received up to two doses, one at the beginning of the study and another 12 weeks later.

Subjects were monitored for 1 hour after injection and called to check on their safety 1 day after.

Subjects recorded their temperature and side effects for 7 days after each vaccination.

Subjects were provided with a thermometer to measure their temperature and a ruler to measure any changes if these occurred on their skin at the injection site.

At all visits, subjects were checked for health changes or problems. They may have had blood drawn.

At some visits, subjects had samples collected from their nose and mouth.


Options:
A: Arm Label: Group 1: RSV vaccine; Type: EXPERIMENTAL; Interventions: Biological: RSV ΔNS2 Δ1313 I1314L Vaccine | Arm Label: Group 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Arm Label: Group 2: RSV vaccine; Type: EXPERIMENTAL; Interventions: Biological: RSV ΔNS2 Δ1313 I1314L Vaccine | Arm Label: Group 2: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Arm Label: Group 3: RSV vaccine; Type: EXPERIMENTAL; Interventions: Biological: RSV ΔNS2 Δ1313 I1314L Vaccine | Arm Label: Group 3: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Arm Label: Group 4: RSV vaccine; Type: EXPERIMENTAL; Interventions: Biological: RSV ΔNS2 Δ1313 I1314L Vaccine | Arm Label: Group 4: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: RSV ΔNS2 Δ1313 I1314L Vaccine; Assigned to Arm(s): Group 1: RSV vaccine, Group 2: RSV vaccine, Group 3: RSV vaccine, Group 4: RSV vaccine | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Group 1: Placebo, Group 2: Placebo, Group 3: Placebo, Group 4: Placebo
B: Arm Label: Group 1 Standard; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Group 2 Enhanced Standard; Type: ACTIVE_COMPARATOR; Interventions: Other: Supplemental training, education and hygiene | Arm Label: Group 3 Chlorhexidine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Chlorhexidine gluconate, Other: Supplemental training, education and hygiene | Intervention Type: DRUG; Name: Chlorhexidine gluconate; Assigned to Arm(s): Group 3 Chlorhexidine | Intervention Type: OTHER; Name: Supplemental training, education and hygiene; Assigned to Arm(s): Group 2 Enhanced Standard, Group 3 Chlorhexidine
C: Arm Label: Treatment Group A; Type: PLACEBO_COMPARATOR; Interventions: Biological: Formulation buffer | Arm Label: Treatment Group; Type: ACTIVE_COMPARATOR; Interventions: Biological: RSV F vaccine with adjuvant | Intervention Type: BIOLOGICAL; Name: RSV F vaccine with adjuvant; Assigned to Arm(s): Treatment Group | Intervention Type: BIOLOGICAL; Name: Formulation buffer; Assigned to Arm(s): Treatment Group A
D: Arm Label: Group 1: DS-Cav1 (50 mcg); Type: EXPERIMENTAL; Interventions: Biological: VRC-RSVRGP084-00-VP | Arm Label: Group 2: DS-Cav1 (50 mcg) + alum; Type: EXPERIMENTAL; Interventions: Biological: VRC-RSVRGP084-00-VP, Other: Aluminum Hydroxide Suspension | Arm Label: Group 3: DS-Cav1 (150 mcg); Type: EXPERIMENTAL; Interventions: Biological: VRC-RSVRGP084-00-VP | Arm Label: Group 4: DS-Cav1 (150 mcg) + alum; Type: EXPERIMENTAL; Interventions: Biological: VRC-RSVRGP084-00-VP, Other: Aluminum Hydroxide Suspension | Arm Label: Group 5: DS-Cav1 (500 mcg); Type: EXPERIMENTAL; Interventions: Biological: VRC-RSVRGP084-00-VP | Arm Label: Group 6:DS-Cav1 (500 mcg) + alum; Type: EXPERIMENTAL; Interventions: Biological: VRC-RSVRGP084-00-VP, Other: Aluminum Hydroxide Suspension | Intervention Type: BIOLOGICAL; Name: VRC-RSVRGP084-00-VP; Assigned to Arm(s): Group 1: DS-Cav1 (50 mcg), Group 2: DS-Cav1 (50 mcg) + alum, Group 3: DS-Cav1 (150 mcg), Group 4: DS-Cav1 (150 mcg) + alum, Group 5: DS-Cav1 (500 mcg), Group 6:DS-Cav1 (500 mcg) + alum | Intervention Type: OTHER; Name: Aluminum Hydroxide Suspension; Assigned to Arm(s): Group 2: DS-Cav1 (50 mcg) + alum, Group 4: DS-Cav1 (150 mcg) + alum, Group 6:DS-Cav1 (500 mcg) + alum

Answer: D