PMID- 17532101
OWN - NLM
STAT- MEDLINE
DCOM- 20071030
LR  - 20220309
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 25 Suppl 1
DP  - 2007 Sep 3
TI  - Safety, immunogenicity, and antibody persistence of a new meningococcal group A 
      conjugate vaccine in healthy Indian adults.
PG  - A101-7
AB  - We performed a double-blind, randomized, controlled phase I study to assess 
      safety, immunogenicity, and antibody persistence of the new meningococcal group A 
      conjugate vaccine (PsA-TT) in healthy volunteers aged 18-35 years. Of the 74 male 
      subjects enrolled, 24 received the PsA-TT vaccine (Group 1), 25 received the 
      Meningococcal Polysaccharide Vaccine A+C, Pasteur, Lyon, France (Group 2), and 25 
      received the Tetanus Toxoid Vaccine Adsorbed, SIIL, Pune India (Group 3). No 
      immediate reactions were observed. Local and systemic solicited reactions within 
      7 days post-vaccination and unsolicited adverse events (AEs) were mild and 
      similar among the three groups and resolved without sequelae. No serious AEs were 
      notified up to 1 year post-vaccination. Four weeks post-vaccination, a slightly 
      higher proportion of Group 1 subjects had a four-fold increase in SBA titers 
      compared to Group 2 subjects (83% versus 72%, p>0.05). SBA GMTs in Groups 2 and 3 
      were higher than in Group 3 (p<0.05). Serogroup A-specific IgG GMCs were 
      significantly higher in Group 1 than in Groups 2 (p<0.05) and 3 (p<0.05). After 1 
      year SBA titers were significantly higher in Group 1 than in Group 2 (p<0.05). 
      The new PsA-TT vaccine was shown to be safe, immunogenic, and able to elicit 
      persistent functional antibody titers in adults. This opens the prospective for 
      further development and licensure of this vaccine to eliminate epidemic 
      meningitis in sub-Saharan Africa.
FAU - Kshirsagar, Nilima
AU  - Kshirsagar N
AD  - Seth G.S. Medical College & KEM Hospital Parel, Mumbai, India.
FAU - Mur, Naidu
AU  - Mur N
FAU - Thatte, Urmila
AU  - Thatte U
FAU - Gogtay, Nithya
AU  - Gogtay N
FAU - Viviani, Simonetta
AU  - Viviani S
FAU - Preziosi, Marie-Pierre
AU  - Preziosi MP
FAU - Elie, Cheryl
AU  - Elie C
FAU - Findlow, Helen
AU  - Findlow H
FAU - Carlone, George
AU  - Carlone G
FAU - Borrow, Ray
AU  - Borrow R
FAU - Parulekar, Varsha
AU  - Parulekar V
FAU - Plikaytis, Brian
AU  - Plikaytis B
FAU - Kulkarni, Prasad
AU  - Kulkarni P
FAU - Imbault, Nathalie
AU  - Imbault N
FAU - LaForce, F Marc
AU  - LaForce FM
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20070508
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Bacterial/blood/immunology
MH  - Double-Blind Method
MH  - Humans
MH  - India
MH  - Male
MH  - Meningococcal Vaccines/administration & dosage/adverse effects/*immunology
MH  - Neisseria meningitidis, Serogroup A/*immunology
MH  - Vaccines, Conjugate/adverse effects/chemistry/*immunology
EDAT- 2007/05/29 09:00
MHDA- 2007/10/31 09:00
CRDT- 2007/05/29 09:00
PHST- 2007/05/29 09:00 [pubmed]
PHST- 2007/10/31 09:00 [medline]
PHST- 2007/05/29 09:00 [entrez]
AID - S0264-410X(07)00475-6 [pii]
AID - 10.1016/j.vaccine.2007.04.050 [doi]
PST - ppublish
SO  - Vaccine. 2007 Sep 3;25 Suppl 1:A101-7. doi: 10.1016/j.vaccine.2007.04.050. Epub 
      2007 May 8.