PMID- 21799810
OWN - NLM
STAT- MEDLINE
DCOM- 20111206
LR  - 20211020
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 6
IP  - 7
DP  - 2011
TI  - Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria 
      vaccine: randomized phase 1b trial in semi-immune adults & children.
PG  - e22273
LID - 10.1371/journal.pone.0022273 [doi]
LID - e22273
AB  - BACKGROUND: This trial was conducted to evaluate the safety and immunogenicity of 
      two virosome formulated malaria peptidomimetics derived from Plasmodium 
      falciparum AMA-1 and CSP in malaria semi-immune adults and children. METHODS: The 
      design was a prospective randomized, double-blind, controlled, age-deescalating 
      study with two immunizations. 10 adults and 40 children (aged 5-9 years) living 
      in a malaria endemic area were immunized with PEV3B or virosomal influenza 
      vaccine Inflexal(R)V on day 0 and 90. RESULTS: No serious or severe adverse events 
      (AEs) related to the vaccines were observed. The only local solicited AE reported 
      was pain at injection site, which affected more children in the Inflexal(R)V group 
      compared to the PEV3B group (p = 0.014). In the PEV3B group, IgG ELISA endpoint 
      titers specific for the AMA-1 and CSP peptide antigens were significantly higher 
      for most time points compared to the Inflexal(R)V control group. Across all time 
      points after first immunization the average ratio of endpoint titers to baseline 
      values in PEV3B subjects ranged from 4 to 15 in adults and from 4 to 66 in 
      children. As an exploratory outcome, we found that the incidence rate of clinical 
      malaria episodes in children vaccinees was half the rate of the control children 
      between study days 30 and 365 (0.0035 episodes per day at risk for PEV3B vs. 
      0.0069 for Inflexal(R)V; RR  = 0.50 [95%-CI: 0.29-0.88], p = 0.02). CONCLUSION: 
      These findings provide a strong basis for the further development of multivalent 
      virosomal malaria peptide vaccines. TRIAL REGISTRATION: ClinicalTrials.gov 
      NCT00513669.
FAU - Cech, Patrick Georges
AU  - Cech PG
AD  - Swiss Tropical and Public Health Institute, Basel, Switzerland.
FAU - Aebi, Thomas
AU  - Aebi T
FAU - Abdallah, Mwanajaa Shomari
AU  - Abdallah MS
FAU - Mpina, Maxmillian
AU  - Mpina M
FAU - Machunda, Ester Barnabas
AU  - Machunda EB
FAU - Westerfeld, Nicole
AU  - Westerfeld N
FAU - Stoffel, Sabine Alexandra
AU  - Stoffel SA
FAU - Zurbriggen, Rinaldo
AU  - Zurbriggen R
FAU - Pluschke, Gerd
AU  - Pluschke G
FAU - Tanner, Marcel
AU  - Tanner M
FAU - Daubenberger, Claudia
AU  - Daubenberger C
FAU - Genton, Blaise
AU  - Genton B
FAU - Abdulla, Salim
AU  - Abdulla S
LA  - eng
SI  - ClinicalTrials.gov/NCT00513669
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110722
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Antigens, Protozoan)
RN  - 0 (Malaria Vaccines)
RN  - 0 (Membrane Proteins)
RN  - 0 (Peptidomimetics)
RN  - 0 (Protozoan Proteins)
RN  - 0 (Virosomes)
RN  - 0 (apical membrane antigen I, Plasmodium)
RN  - 0 (circumsporozoite protein, Protozoan)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antigens, Protozoan/*chemistry
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Malaria/epidemiology/prevention & control
MH  - Malaria Vaccines/*administration & dosage/adverse effects/*immunology
MH  - Male
MH  - Membrane Proteins/*chemistry
MH  - Middle Aged
MH  - Peptidomimetics/*administration & dosage/adverse effects/*immunology
MH  - Plasmodium falciparum/*immunology
MH  - Protozoan Proteins/*chemistry
MH  - Virosomes
MH  - Young Adult
PMC - PMC3142124
OTO - NOTNLM
OT  - Tanzania
OT  - efficacy
OT  - immunogenicity
OT  - malaria
OT  - peptide
OT  - safety
OT  - vaccine
OT  - virosomes
COIS- Competing Interests: NW, SAS and RZ were employees of Pevion Biotech Ltd. during 
      the trial. RZ and GP are named as inventors in patents covering the vaccines 
      tested. By the end of 2007, Mymetics S.A., Lausanne, Switzerland took over the 
      responsibility of this project from Pevion Biotech Ltd. PC's curent affiliation 
      is with F. Hoffmann-La Roche Ltd., Basel, Switzerland and RZ's current 
      affiliation is with Lonza Ltd., Visp, Switzerland. This does not alter the 
      authors' adherence to all the PLoS ONE policies on sharing data and materials.
EDAT- 2011/07/30 06:00
MHDA- 2011/12/13 00:00
PMCR- 2011/07/22
CRDT- 2011/07/30 06:00
PHST- 2011/02/03 00:00 [received]
PHST- 2011/06/22 00:00 [accepted]
PHST- 2011/07/30 06:00 [entrez]
PHST- 2011/07/30 06:00 [pubmed]
PHST- 2011/12/13 00:00 [medline]
PHST- 2011/07/22 00:00 [pmc-release]
AID - PONE-D-11-02665 [pii]
AID - 10.1371/journal.pone.0022273 [doi]
PST - ppublish
SO  - PLoS One. 2011;6(7):e22273. doi: 10.1371/journal.pone.0022273. Epub 2011 Jul 22.