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Table 1 Time and event schedule for baseline and regularly scheduled follow-up visits in the PREVAC study

From: Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries

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

  1. a)Birth month and year, gender
  2. b)Contact information for self and 2 contacts who will know how to locate the volunteer
  3. c)Role as health care worker, contact with persons known to have EVD