Please select the outcome measures that correspond 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: Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the intensive monitoring phase of the study (Measured at Days 0-10 for seropositive children and Days 0-28 for seronegative infants and children); Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination (Measured through follow-up period, up to 1 year after study entry)
B: Incidence of Skin and Soft Tissue Infection (SSTI) (At the end of the 20 month study); Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI (At the end of the 20 month study)
C: Incidence of medically significant RSV LRTI with either hypoxemia (SpO2 <95% at sea level or <92% at altitudes >1800 meters) or tachypnea in infants through 90 days of life (Delivery to 90 days after delivery)
D: 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 (7 days after the first product administration (Day 7)); 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 (7 days after the second product administration (Day 91)); Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after each product administration); 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 (7 days after the first product administration (Day 7)); 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 (7 days after the second product administration (Day 91)); Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after each product administration); Number of Subjects With Abnormal Laboratory Measures of Safety (Day 0 through Day 308); Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) (Day 0 through Day 28 after product administration); Number of Subjects With Serious Adverse Events (SAEs) (Day 0 through Day 308); Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration (Day 0 through Day 308)

Answer: D