PMID- 37160281
OWN - NLM
STAT- MEDLINE
DCOM- 20230707
LR  - 20230718
IS  - 1476-1645 (Electronic)
IS  - 0002-9637 (Print)
IS  - 0002-9637 (Linking)
VI  - 109
IP  - 1
DP  - 2023 Jul 5
TI  - Safety and Immunogenicity of Radiation-Attenuated PfSPZ Vaccine in Equatoguinean 
      Infants, Children, and Adults.
PG  - 138-146
LID - 10.4269/ajtmh.22-0773 [doi]
AB  - The radiation-attenuated Plasmodium falciparum sporozoites (PfSPZ) Vaccine has 
      demonstrated safety and immunogenicity in 5-month-old to 50-year-old Africans in 
      multiple trials. Except for one, each trial has restricted enrollment to either 
      infants and children or adults < 50 years old. This trial was conducted in 
      Equatorial Guinea and assessed the safety, tolerability, and immunogenicity of 
      three direct venous inoculations of 1.8 x 106 or 2.7 x 106 PfSPZ, of PfSPZ 
      Vaccine, or normal saline administered at 8-week intervals in a randomized, 
      double-blind, placebo-controlled trial stratified by age (6-11 months and 1-5, 
      6-10, 11-17, 18-35, and 36-61 years). All doses were successfully administered. 
      In all, 192/207 injections (93%) in those aged 6-61 years were rated as causing 
      no or mild pain. There were no significant differences in solicited adverse 
      events (AEs) between vaccinees and controls in any age group (P >/= 0.17). There 
      were no significant differences between vaccinees and controls with respect to 
      the rates or severity of unsolicited AEs or laboratory abnormalities. Development 
      of antibodies to P. falciparum circumsporozoite protein occurred in 67/69 
      vaccinees (97%) and 0/15 controls. Median antibody levels were highest in infants 
      and 1-5-year-olds and declined progressively with age. Antibody responses in 
      children were greater than in adults protected against controlled human malaria 
      infection. Robust immunogenicity, combined with a benign AE profile, indicates 
      children are an ideal target for immunization with PfSPZ Vaccine.
FAU - Jongo, Said A
AU  - Jongo SA
AD  - Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, 
      Tanzania.
FAU - Urbano Nsue Ndong Nchama, Vicente
AU  - Urbano Nsue Ndong Nchama V
AD  - Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, 
      Equatorial Guinea.
FAU - Church, L W Preston
AU  - Church LWP
AD  - Sanaria Inc., Rockville, Maryland.
FAU - Olotu, Ally
AU  - Olotu A
AD  - Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, 
      Tanzania.
FAU - Manock, Stephen R
AU  - Manock SR
AD  - Sanaria Inc., Rockville, Maryland.
FAU - Schindler, Tobias
AU  - Schindler T
AD  - Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
AD  - University of Basel, Basel, Switzerland.
FAU - Mtoro, Ali
AU  - Mtoro A
AD  - Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, 
      Tanzania.
FAU - Kc, Natasha
AU  - Kc N
AD  - Sanaria Inc., Rockville, Maryland.
AD  - Protein Potential LLC, Rockville, Maryland.
FAU - Devinsky, Orrin
AU  - Devinsky O
AD  - New York University Langone Medical Center, New York, New York.
FAU - Zan, Elcin
AU  - Zan E
AD  - New York University Langone Medical Center, New York, New York.
FAU - Hamad, Ali
AU  - Hamad A
AD  - Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, 
      Tanzania.
FAU - Nyakarungu, Elizabeth
AU  - Nyakarungu E
AD  - Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, 
      Tanzania.
FAU - Mpina, Maxmillian
AU  - Mpina M
AD  - Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, 
      Tanzania.
AD  - Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
AD  - University of Basel, Basel, Switzerland.
FAU - Deal, Anna
AU  - Deal A
AD  - Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
AD  - University of Basel, Basel, Switzerland.
FAU - Bijeri, Jose Raso
AU  - Bijeri JR
AD  - Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, 
      Equatorial Guinea.
FAU - Ondo Mangue, Martin Eka
AU  - Ondo Mangue ME
AD  - Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, 
      Equatorial Guinea.
FAU - Ntutumu Pasialo, Beltran Ekua
AU  - Ntutumu Pasialo BE
AD  - Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, 
      Equatorial Guinea.
FAU - Nguema, Genaro Nsue
AU  - Nguema GN
AD  - Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, 
      Equatorial Guinea.
FAU - Rivas, Matilde Riloha
AU  - Rivas MR
AD  - Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, 
      Equatorial Guinea.
FAU - Chemba, Mwajuma
AU  - Chemba M
AD  - Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, 
      Tanzania.
FAU - Ramadhani, Kamaka K
AU  - Ramadhani KK
AD  - Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, 
      Tanzania.
FAU - James, Eric R
AU  - James ER
AD  - Sanaria Inc., Rockville, Maryland.
FAU - Stabler, Thomas C
AU  - Stabler TC
AD  - Sanaria Inc., Rockville, Maryland.
FAU - Abebe, Yonas
AU  - Abebe Y
AD  - Sanaria Inc., Rockville, Maryland.
FAU - Riyahi, Pouria
AU  - Riyahi P
AD  - Sanaria Inc., Rockville, Maryland.
FAU - Saverino, Elizabeth S
AU  - Saverino ES
AD  - Sanaria Inc., Rockville, Maryland.
FAU - Sax, Julian
AU  - Sax J
AD  - Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
FAU - Hosch, Salome
AU  - Hosch S
AD  - Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
AD  - University of Basel, Basel, Switzerland.
FAU - Tumbo, Anneth
AU  - Tumbo A
AD  - Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, 
      Tanzania.
AD  - Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
AD  - University of Basel, Basel, Switzerland.
FAU - Gondwe, Linda
AU  - Gondwe L
AD  - Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, 
      Tanzania.
FAU - Segura, J Luis
AU  - Segura JL
AD  - Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
AD  - University of Basel, Basel, Switzerland.
FAU - Falla, Carlos Cortes
AU  - Falla CC
AD  - MCD Global Health, Silver Spring, Maryland.
FAU - Phiri, Wonder Philip
AU  - Phiri WP
AD  - MCD Global Health, Silver Spring, Maryland.
FAU - Hergott, Dianna E B
AU  - Hergott DEB
AD  - MCD Global Health, Silver Spring, Maryland.
FAU - Garcia, Guillermo A
AU  - Garcia GA
AD  - MCD Global Health, Silver Spring, Maryland.
FAU - Maas, Carl
AU  - Maas C
AD  - Marathon EG Production, Ltd., Malabo Dos, Equatorial Guinea.
FAU - Murshedkar, Tooba
AU  - Murshedkar T
AD  - Sanaria Inc., Rockville, Maryland.
FAU - Billingsley, Peter F
AU  - Billingsley PF
AD  - Sanaria Inc., Rockville, Maryland.
FAU - Tanner, Marcel
AU  - Tanner M
AD  - Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
AD  - University of Basel, Basel, Switzerland.
FAU - Ayekaba, Mitoha Ondo'o
AU  - Ayekaba MO
AD  - Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, 
      Equatorial Guinea.
FAU - Sim, B Kim Lee
AU  - Sim BKL
AD  - Sanaria Inc., Rockville, Maryland.
AD  - Protein Potential LLC, Rockville, Maryland.
FAU - Daubenberger, Claudia
AU  - Daubenberger C
AD  - Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
AD  - University of Basel, Basel, Switzerland.
FAU - Richie, Thomas L
AU  - Richie TL
AD  - Sanaria Inc., Rockville, Maryland.
FAU - Abdulla, Salim
AU  - Abdulla S
AD  - Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, 
      Tanzania.
FAU - Hoffman, Stephen L
AU  - Hoffman SL
AD  - Sanaria Inc., Rockville, Maryland.
LA  - eng
SI  - ClinicalTrials.gov/NCT02859350
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230509
PL  - United States
TA  - Am J Trop Med Hyg
JT  - The American journal of tropical medicine and hygiene
JID - 0370507
RN  - 0 (Vaccines, Attenuated)
RN  - 0 (Malaria Vaccines)
SB  - IM
MH  - Animals
MH  - Adult
MH  - Humans
MH  - Child
MH  - Infant
MH  - Child, Preschool
MH  - Middle Aged
MH  - Plasmodium falciparum
MH  - *Malaria, Falciparum/prevention & control
MH  - Sporozoites
MH  - Vaccines, Attenuated
MH  - Equatorial Guinea
MH  - *Malaria Vaccines
MH  - Double-Blind Method
MH  - Immunogenicity, Vaccine
PMC - PMC10324022
EDAT- 2023/05/10 00:41
MHDA- 2023/07/07 06:42
PMCR- 2023/05/09
CRDT- 2023/05/09 20:02
PHST- 2022/12/13 00:00 [received]
PHST- 2023/03/08 00:00 [accepted]
PHST- 2023/07/07 06:42 [medline]
PHST- 2023/05/10 00:41 [pubmed]
PHST- 2023/05/09 20:02 [entrez]
PHST- 2023/05/09 00:00 [pmc-release]
AID - tpmd220773 [pii]
AID - 10.4269/ajtmh.22-0773 [doi]
PST - epublish
SO  - Am J Trop Med Hyg. 2023 May 9;109(1):138-146. doi: 10.4269/ajtmh.22-0773. Print 
      2023 Jul 5.