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Vaccine Detail

Group A streptococcal recombinant fusion peptide Vaccine
Vaccine Information
  • Vaccine Ontology ID: VO_0004247
  • Type: Subunit vaccine
  • Status: Clinical trial
  • Adjuvant: Rehydragel LV
  • Immunization Route: Intramuscular injection (i.m.)
  • Description: A recombinant fusion peptide group A streptococcal vaccine containing N-terminal M protein fragments from serotypes 1, 3, 5, 6, 19, and 24 (Kotloff et al., 2004).
Host Response

Human Response

  • Vaccination Protocol: Twenty-eight healthy adults aged 18 to 50 years were vaccinated. Groups of volunteers received 3 spaced intramuscular injections of either 50-µg (n = 8), 100-µg (n = 10), or 200-µg (n = 10) doses of vaccine into the deltoid muscle of alternating arms. Escalation to a higher dose level required approval by an independent data and safety monitoring committee that reviewed all data from recipients of the lower dose group collected between day 0 until 14 days after the third inoculation. A day 0, 28, and 56 dosing schedule was chosen initially. When 1 of 8 recipients of a 50-µg dose experienced moderate induration and pruritus at the injection site following the third injection, the sponsor and independent data and safety monitoring committee recommended that the dosing schedule for subsequent groups be changed to 0, 28, and 112 days (Kotloff et al., 2004).
  • Immune Response: Vaccination elicited 4-fold or more increases in 40 (83%) of 48 possible assays (ie, 6 antigens × 8 volunteers) following the 50-µg dose, in 45 (75%) of 60 possible assays (ie, 6 antigens × 10 volunteers) following the 100-µg dose, and in 57 (95%) of 60 possible assays (ie, 6 antigens × 10 volunteers) following the 200-µg dose. The geometric mean antibody titer following vaccination was significantly higher than the prevaccination titer for each antigen measured in all dose groups (Kotloff et al., 2004).
  • Side Effects: Vaccination was well-tolerated. Local erythema, swelling, or tenderness were detected in 6 (21%) of 29 participants within 7 days after the first inoculation and 12 (43%) of 28 participants each after the second and third inoculations. All local reactions were graded as mild (≤30 mm and easily tolerated) with the exception of the aforementioned participant who developed moderate (31-80 mm) erythema, swelling, and itching for 1 day after the third dose of 50 µg (Kotloff et al., 2004).
References
Kotloff et al., 2004: Kotloff KL, Corretti M, Palmer K, Campbell JD, Reddish MA, Hu MC, Wasserman SS, Dale JB. Safety and immunogenicity of a recombinant multivalent group a streptococcal vaccine in healthy adults: phase 1 trial. JAMA : the journal of the American Medical Association. 2004; 292(6); 709-715. [PubMed: 15304468].