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Vaccine Detail

PvDBPII/Matrix-M1
Vaccine Information
  • Vaccine Name: PvDBPII/Matrix-M1
  • Target Pathogen: Plasmodium spp.
  • Target Disease: Malaria
  • Type: Subunit vaccine
  • Status: Clinical trial
  • Host Species for Licensed Use: Human
  • Antigen: PvDBPII: region II of P. vivax Duffy-binding protein (Hou et al., 2022)
  • PvDBPII gene engineering:
    • Type: Recombinant protein preparation
    • Description: Region II of PvDBP, a 327-amino acid domain. (Hou et al., 2022)
    • Detailed Gene Information: Click Here.
  • Adjuvant: Matrix-M vaccine adjuvant
    • Adjuvant name: Matrix-M vaccine adjuvant
    • VO adjuvant ID: VO_0005206
  • Immunization Route: Intramuscular injection (i.m.)
Host Response

Human Response

  • Host Strain: healthy adults living in the UK (Minassian et al., 2019)
  • Vaccination Protocol: Phase I/IIa, blood-stage trial
    Volunteers received vaccination based on the time they participated in the experiment: group 1 received three doses of the PvDBPII 50ug/Matrix M1 50ug vaccine at 0, 1 and 14 months, and group 2 received three doses of the PvDBPII 50ug/Matrix M1 50ug vaccine at 0, 1 and 2 months. (Hou et al., 2022)
  • Immune Response: Humoral: Anti-PvDBPII (SalI) total IgG serum antibody responses peaked around 2 weeks following the final vaccination. PvDBPII/M-M given at 0, 1 and 14 months induced higher response (geometric mean 198 μg/mL, range 153–335).
    Cellular: PvDBPII-specific CD4+ CD45RA− CCR7− effector memory T cells producing IFN-γ were detectable following final vaccinations in a delayed dosing regimen. IFN-γ producing CD8+ effector memory T cells were not detectable. (Hou et al., 2022)
  • Side Effects: Mild or moderate cases of warmth, itch, injection site pain, redness, malaise, nausea, fatigue, headache, feverishness, myalgia, arthralgia, and temperature, all resolved within 48 hours. (Hou et al., 2022)
  • Challenge Protocol: Blood stage CHMI 2–4 weeks after the third dose of vaccination (Hou et al., 2022)
  • Efficacy: All volunteers developed parasitemia, but the PMR and LCP is significant lower in the delayed dosing group compared to unvaccinated controls, due to the delayed dosing (PMR: 3.2-fold growth per 48 hours (range 2.3 to 4.3) compared to 6.8-fold growth per 48 hours [range 4.0 to 11.1], p <0.001), resulted in a 7-day delay in median time to reach malaria diagnosis (15.5 days in controls compared to 22.5 days in delayed dosing group). (Hou et al., 2022)
References
Hou et al., 2022: Hou MM, Barrett JR, Themistocleous Y, Rawlinson TA, Diouf A, Martinez FJ, Nielsen CM, Lias AM, King LDW, Edwards NJ, Greenwood NM, Kingham L, Poulton ID, Khozoee B, Goh C, Mac Lochlainn DJ, Salkeld J, Guilotte-Blisnick M, Huon C, Mohring F, Reimer JM, Chauhan VS, Mukherjee P, Biswas S, Taylor IJ, Lawrie AM, Cho JS, Nugent FL, Long CA, Moon RW, Miura K, Silk SE, Chitnis CE, Minassian AM, Draper SJ. Impact of a blood-stage vaccine on Plasmodium vivax malaria. medRxiv : the preprint server for health sciences. 2022; ; . [PubMed: 35664997].
Minassian et al., 2019: Safety, Immunogenicity and Efficacy of the Blood-stage Plasmodium Vivax Malaria Vaccine Candidate PvDBPII in Matrix M1 [https://clinicaltrials.gov/ct2/show/NCT04201431?term=vaccine&cond=Malaria%2C+Vivax&draw=2&rank=1]