Table 1: Baseline characteristics of participants.
Age presented is age at enrollment (day of vaccine #1). AOne subject randomized to Pfs230D1, 40μg + normal saline was erroneously administered comparator for vaccination #1; reviewed by study team, statistician, Sponsor, and DSMB and recommended the subject continue to receive comparator for the rest of the study (subject and clinical team remained blinded); for analysis considered comparator subject (for as-treated analysis) and Pfs230D1 subject (for ITT). BUrine and stool samples were obtained from subjects during screening. Urine schistosomiasis screening was completed on site and positive subjects were treated with praziquantel; all enrolled subjects underwent urinary schistosomiasis testing. Urinary S. haematobium was further quantified for density of infection (slightly infected = 1-49 eggs/10mL of urine; moderately infected = 50-100 eggs/10mL; heavily infected = >100 eggs/10mL of urine) – all reported infections were slightly infected except 1 subject with heavily infected sample (main cohort TWINRIX/Menactra + normal saline subject). Stool PCR was completed retrospectively at NIH and did not impact clinical care; testing was completed for the following pathogens and grouped accordingly: Helminth: Ascaris lumbricoides (nematode/roundworm), Trichuris trichiura (nematode/roundworm), Strongyloides stercoralis (nematode/roundworm), Necator americanus (hookworm), Ancylostoma duodenale (hookworm), Protozoa: Giardia lamblia, Cryptospordium parvum/hominis, Entamoeba histolytica. Stool (no result) = either stool not collected, assay not completed, or NIC. S. haematobium = Schistosoma haematobium. Calculated % for stool results are based off assayed results (Pilot safety cohort: Pfs25, n=4; Pfs230, n=4; Pfs25 + Pfs230, n=5; TWINRIX +/− NS, n=10; main cohort: Pfs25 + NS, n=31; Pfs230D1 + NS, n=27; Pfs25 + Pfs230, n=33; TWINRIX, Menactra + NS, n=26). CParasitemia defined as blood smear >0 asexual Plasmodium falciparum on day of vaccine 1 (study day 0) or on day of vaccine 4 (main cohort only; study day 540). Gametocytemia is defined as blood smear >0 gametocytes (sexual Plasmodium falciparum) seen by at least one reader on day of vaccine 1 (study day 0) or on day of vaccine 4 (main cohort only; study day 540). DFor prior to dose four, n/arm (main cohort only) shifted to Pfs25 + NS, n=42; Pfs230D1 + NS, n=40; Pfs25 + Pfs230, n=39; TWINRIX, Menactra + NS, n=40. Pfs25 = Pfs25-EPA/Alhydrogel®; Pfs230 = Pfs230D1-EPA/Alhydrogel®; μg = micrograms; SD = standard deviation. Min = minimum. Max = maximum. N/A = not applicable.
| Pilot Safety Cohort | Main Cohort | |||||||
|---|---|---|---|---|---|---|---|---|
| Pfs25, 16 μg (N=5) |
Pfs230D 1, 15 μg (N=5) |
Pfs25, 16 μg + Pfs230D 1, 15 μg (N=5) |
TWINRI X +/− NS (N=10) |
Pfs25, 47 μg + NS (N=50) |
Pfs230D 1, 40 μg + NS (N=49)A |
Pfs25, 47 μg + Pfs230D 1, 40 μg (N=50) |
TWINRIX/Mena ctra + NS (N=51)A |
|
| Gender | ||||||||
| Male | 4 (80%) | 4 (80%) | 4 (80%) | 8 (80%) | 35 (70%) | 33 (67%) | 36 (72%) | 36 (71%) |
| Age | ||||||||
| Mean ± SD | 35·6 ± 12·5 | 38·6 ± 8·9 | 34·6 ± 10·3 | 31·5 ± 10·2 | 38 ± 9·3 | 38·3 ± 8·8 | 36·6 ± 9·5 | 37·8 ± 10·4 |
| Min, Max | 19, 50 | 29, 48 | 19, 46 | 19, 47 | 18, 50 | 19, 50 | 19, 50 | 18, 50 |
| Village | ||||||||
| Bancoumana | 5 (100%) | 5 (100%) | 5 (100%) | 10 (100%) | 29 (58%) | 24 (49%) | 28 (56%) | 22 (43%) |
| Koursale | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 5 (10%) | 6 (12%) | 7 (14 %) | 7 (14%) |
| Kolle | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 6 (12%) | 6 (12%) | 3 (6%) | 3 (6%) |
| Samako | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 5 (10%) | 4 (8%) | 6 (12%) | 8 (16%) |
| Nankilabougou | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2%) | 0 (0%) |
| Missira | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2%) | 0 (0%) | 1 (2%) | 0 (0%) |
| Djiguidala | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2%) | 1 (2%) | 1 (2%) | 2 (4%) |
| Tema | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2%) | 2 (4%) | 1 (2%) | 3 (6%) |
| Djoliba | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (4%) | 6 (12%) | 2 (4%) | 6 (12%) |
| Co-infectionsB | ||||||||
| Urinary S. haematobium | 0 (0%) | 0 (0%) | 0 (0%) | 1 (10%) | 3 (6%) | 2 (4%) | 4 (8%) | 5 (10%) |
| Stool helminth | 1 (25%) | 0 (0%) | 1 (20%) | 2 (20%) | 6 (19%) | 4 (15%) | 7 (21%) | 4 (15%) |
| Stool protozoa | 2 (50%) | 2 (50%) | 0 (0%) | 5 (50%) | 14(45%) | 15 (56%) | 13 (39%) | 6 (23%) |
| Stool (no result) | 1 (20%) | 1 (20%) | 0 (0%) | 0 (0%) | 19 (38%) | 22 (45%) | 17 (34%) | 25 (49%) |
| ParasitemiaC | ||||||||
| Prior to dose 1 | 1 (20%) | 1 (20%) | 1 (20%) | 0 (0%) | 4 (8%) | 6 (12%) | 6 (12%) | 9 (18%) |
| Prior to dose 4D | N/A | N/A | N/A | N/A | 4 (10%) | 7 (18%) | 0 (0%) | 6 (15%) |
| GametocytemiaC | ||||||||
| Prior to dose 1 | 1 (20%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (4%) | 1 (2%) | 4 (8%) |
| Prior to dose 4D | N/A | N/A | N/A | N/A | 5 (12%) | 8 (20%) | 2 (5%) | 1 (3%) |