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Table 3 Schedule of activities—women in group B

From: Safety, reactogenicity, and immunogenicity of a 2-dose Ebola vaccine regimen of Ad26.ZEBOV followed by MVA-BN-Filo in healthy adult pregnant women: study protocol for a phase 3 open-label randomized controlled trial

Visit #

1

2

3

4

5

6

7

8

9a

10n

11 a

EE

Visit timingp

 

Randomiz-ation (D1)

D1 + 28 days

D1 + 56 days

D1 + 12 weeks

Pregnancy completion/

termination

Dose 1

Dose 2

Dose 2 + 

21 days

Dose 2 + 

28 days

Dose 1 + 

365 days

Early

exit

Visit day and window

-28 to 1

D1

D29 ± 7 days

D57

 − 14 days, + 28 days

D85 ± 7 days

PP 1 b

 + 2 days

PP 43 c

 + 28 days

PP 99

-14 days, + 28 days

PP 120

 ± 14 days

PP 127

 ± 3 days

Dose 1 + 365 ± 28 days

 

Visit type

Screening

Random-ization

Safety

Safety

Safety

Safety and immuno

DOSE 1 group B

DOSE 2 group B

Safety and immuno

Safety

Safety and immuno

Early exit

Assessment of understanding

           

Written informed consent (ICF) d

           

Inclusion/exclusion criteria

          

Demographics e

           

Medical and obstetric history f and prestudy meds

           

Physical examination f

     

   

Obstetric exam f

   

     

o

Targeted physical examination f

 

   

 

Vital signs f incl. body temperature

• 

Urine pregnancy test g

     

    

Hematology, chemistry g

           

Urine dipstick/urinalysis g

       

Syphilis, HIV, hepatitis B and C, malaria screening g

           

Obstetric ultrasound h

h

  

      

o

Biometric scan

 

Contact information

Randomization

 

          

Pre-vaccination symptomsi

      

    

Vaccination

      

    

30 min post-vaccination observation j

      

    

Adverse maternal, fetal outcomes

 

     

SAE recording

 

Concomitant medications k

Delivery history l

     

      

Post pregnancy physical examination l

     

      

Laboratory assessments m

     

      

Group B immunology subset supplemental procedures (N = 150)

1

2

3

4

5

6

7

8

9

10

11

EE

Humoral immunogenicity sample (serum)

      

 

 

 

Breast milk sample (N = 10)

      

     
  1.  pre-dose; pre- and post-dose
  2. aVisits 9 and 11 for group B immunology subset participants only
  3. bPP1 refers to the day of pregnancy completion/termination. Visit 6 (PP1) should occur on the day of pregnancy completion/termination or within 2 days
  4. cVisit 7 (PP 43) scheduled to occur at routine 6 week post-partum visit
  5. dMust be signed before first study-related activity
  6. eMaternal demographic information to be collected at screening includes: date of birth, race/ethnicity, education level, geographical location/residence, occupation, household size (number of persons living in the same home), and international travel history
  7. fInformation to be collected for medical and obstetric history, physical exams, and vital signs is specified in the protocol
  8. gUrine dipstick for protein and glucose results will be performed at these visits. If results are 1 + or greater, then additional work-up for pre-eclampsia or gestational diabetes may be warranted
  9. hUltrasound not required at visit 2 if screening (visit 1) ultrasound completed within past 10 days and no other indication for ultrasound
  10. iInvestigator must check for acute illness or body temperature ≥ 38.0 °C at the time of vaccination. In such cases, the participant may be vaccinated at later time point
  11. jParticipants will be closely observed for a minimum of 30 min post-vaccination
  12. kIncludes any medical treatment/medications given to the mother during delivery (e.g., antibiotic prophylaxis)-specifying names of medications administered
  13. lInformation to be collected for delivery history and post-pregnancy examination is specified in the protocol
  14. mAny routine laboratory assessment performed at time of delivery and other laboratory tests as medically indicated
  15. nVisit 10: for women not part of the immunogenicity subset this visit will be the end of the trial
  16. oNot required if participant is not pregnant
  17. pIf pregnancy completion/termination in a group B woman occurs prior to performing all in-pregnancy protocol visits, these missed visits will not be considered as protocol deviations