Table 1.
Time and event schedule for baseline and regularly scheduled follow-up visits in the PREVAC study
| Events | Adults | Children |
|---|---|---|
| Screening (children must have a documented negative HIV test prior to randomization) | X | |
| Baseline | ||
| Informed consent/assent | X | X |
| Initial vaccination | X | X |
| Demographics a) | X | X |
| Contact information b) | X | X |
| Indicators of increased risk c) | X | X |
| Height, weight and temperature | X | X |
| Mid-upper arm circumference for children 1–5 years | X | |
| Pregnancy test for females of child-bearing potential, i.e., females who have experienced menarche or who are aged 14 years and older | X | X |
| Blood sample for immunogenicity testing and future research | X | X |
| Blood sample for chemistries and CBC | X | X |
| Blood sample for HIV/syphilis testing | X | X |
| Saliva sample for assessing viral shedding (subsample) | X | |
| Stored blood for assessing T cell and memory B cell function in a subset of participants in Guinea | X | |
| Injection site reactions, targeted symptoms of any grade severity, and grade 3 or 4 AEs following prime vaccination | X | X |
| HIV pre-counseling | X | X |
| Days 1 to 6 following prime and booster vaccination | ||
| Contact for injection site reactions, targeted symptoms of any grade severity, grade 3 or 4 AEs, measurement of temperature, and possible SAEs in children | X | |
| Day 7 and day 63 | ||
| Injection site reactions, targeted symptoms of any grade severity, and grade 3 or 4 AEs | X | X |
| Blood sample for immunogenicity testing and future research | X | X |
| Saliva sample for assessing viral shedding (subsample) | X | |
| Blood sample for assessing T cell and memory B cell function in a subset of adults in Guinea | X | |
| HIV and syphilis post-counseling referral | X | X |
| Blood sample for chemistries and CBC | X | |
| Temperature | X | X |
| Day 14 | ||
| Injection site reactions, targeted symptoms of any grade severity, and grade 3 or 4 AEs | X | X |
| Temperature | X | X |
| Blood sample for immunogenicity testing and future research | X | X |
| Saliva sample for assessing viral shedding (subsample) | X | |
| Blood sample for assessing T cell and memory B Cell function in a subset of adults in Guinea | X | |
| Day 28 | ||
| Injection site reactions, targeted symptoms of any grade severity, and grade 3 or 4 AEs | X | X |
| Temperature | X | X |
| Weight | X | |
| Blood sample for immunogenicity testing and future research | X | X |
| Saliva sample for assessing viral shedding (subsample) | X | |
| Day 56 | ||
| Booster vaccination | X | X |
| Blood sample for immunogenicity testing and future research | X | X |
| Pregnancy test for females of childbearing potential, i.e., females who have experienced menarche or who are aged 14 years and older | X | X |
| Temperature | X | X |
| Injection site reactions, targeted symptoms of any grade severity, and grade 3 or 4 AEs following booster vaccination | X | X |
| Saliva sample for assessing viral shedding (subsample) | X | |
| Blood sample for assessing T cell and memory B cell function in a subset of adults in Guinea | X | |
| Day 70 | ||
| Blood sample for assessing T cell and memory B cell function in a subset of adults in Guinea | X | |
| Months 3 and 6 | ||
| Injection site reactions, targeted symptoms of any grade severity, and grade 3 or 4 AEs (Month 3 only) | X | X |
| Temperature | X | X |
| Weight | X | |
| Mid-upper arm circumference for children 1–5 years | X | |
| Blood sample for immunogenicity testing and future research | X | X |
| Saliva sample for assessing viral shedding (subsample at month 3 only) | X | |
| Months 12, 24, 36, 48, and 60 | ||
| Temperature | X | X |
| Weight | X | |
| Height | X | |
| Mid-upper arm circumference for children 1–5 years | X | |
| Blood sample for immunogenicity testing and future research | X | X |
| Survey data for the study on barriers and facilitators to PREVAC retention | X | X |
| Blood sample for the parasitology assays for the malaria substudy in Sierra Leone and in Guinea (Landreah site) | X | X |
| Blood sample for assessing T cell and memory B cell function in a subset of adults in Guinea | X | |
| SAEs throughout follow-up | X | X |
| EVD events (reported as soon as aware) throughout follow-up and where possible a stored blood sample for future research | X | X |
| Death (reported as soon as aware) throughout follow-up | X | X |
| Pregnancy outcome for women who become pregnant in the first 3 months of follow-up after prime vaccination | X | X |
a)Birth month and year, gender
b)Contact information for self and 2 contacts who will know how to locate the volunteer
c)Role as health care worker, contact with persons known to have EVD