Enrollment in a Phase 1 trial of a new investigational universal influenza vaccine candidate has begun at the National Institutes of Health’s Clinical Center in Bethesda, MD. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and will evaluate the investigational vaccine for safety and its ability to elicit an immune response.
Currently available seasonal influenza (or flu) vaccines are effective at preventing specific strains of influenza. Each year, the vaccines are re-evaluated and changed to best match the strains of flu predicted to be the most dominant in the upcoming flu season. Most seasonal flu vaccines are designed to train the immune system to defend against three or four different common strains of flu, but a “universal” influenza vaccine might someday provide protection against many more.
“An ideal universal influenza vaccine could be taken less frequently than once a year and protect against multiple strains of influenza virus. With each new universal influenza vaccine candidate and clinical trial, we take another step closer to that goal,” said acting NIAID director Hugh Auchincloss, MD.
The vaccine candidate under investigation, FluMos-v2, was designed by researchers at NIAID’s Vaccine Research Center (VRC). It is an adaptation of an earlier universal flu vaccine candidate, FluMos-v1, which began first-in-human testing in 2021 and is still undergoing trials.
FluMos-v2 is designed to induce antibodies against many different influenza virus strains by displaying part of the influenza virus hemagglutinin (HA) protein in repeating patterns on self-assembling nanoparticle scaffolds. Exposure to these harmless fragments of virus proteins prepares the immune system to recognize and fight the actual virus. When tested in animals, the experimental vaccine resulted in robust antibody responses.
While the FluMos-v1 vaccine candidate displays HA from four strains of influenza virus, FluMos-v2 displays HA from six: four influenza A viruses and two influenza B viruses. The researchers anticipate that this will further broaden vaccine recipients’ immunity, providing protection against a wider variety of influenza viruses.
The new clinical trial is expected to enroll 24 healthy volunteers, aged 18–50 years, who will receive two intramuscular injections of the FluMos-v2 vaccine candidate. These injections will be given 16 weeks apart. At first, participants will be enrolled in the lower dose group (60 μg per vaccination). If no safety concerns are identified after at least three participants have received this dose, enrollment will begin in the higher dose (180 μg per vaccination) group. The study team plans to enroll 12 participants in each dosage group.
For 40 weeks after their first vaccination, participants will receive regular follow-up phone calls and examinations to track their responses to the experimental vaccine. Blood samples will be taken during study visits to measure any immune responses to the vaccine candidate. Further information about the trial is available at ClinicalTrials.gov.
- This press release was originally published on the National Institute of Allergy and Infectious Diseases website
Uandikishaji katika jaribio la awamu ya kwanza la mtihani mpya wa chanjo ya virusi vya mafua ya ulimwengu umeanza katika Kituo cha Kliniki cha Taasisi za Kitaifa za Afya huko Bethesda, MD. Majaribio hayo yanasaidiwa na Taasisi ya Kitaifa ya Madhara na Madhara (NIAID), sehemu ya NIH, na yatathmini chanjo ya uchunguzi kwa usalama na uwezo wake wa kusababisha majibu ya kinga. Chanjo za mafua ya msimu (au mafua) zinazopatikana kwa sasa zina matokeo katika kuzuia aina fulani za mafua. Kila mwaka, chanjo hizo zinapimwa upya na kubadilishwa ili zifanane na aina za mafua zinazotabiriwa kuwa za kawaida katika msimu ujao wa mafua. Chanjo nyingi za mafua ya msimu zimekusudiwa kuzoeza mfumo wa kinga kujikinga na aina tatu au nne tofauti za mafua, lakini chanjo ya mafua ya "ulimwengu" inaweza siku moja kutoa ulinzi dhidi ya mengi zaidi. <unk> Chanjo bora ya virusi vya mafua inaweza kuchukuliwa mara chache kuliko mara moja kwa mwaka na kulinda dhidi ya aina nyingi za virusi vya mafua. "Kwa kila mgombea mpya wa chanjo ya virusi vya mafua na majaribio ya kliniki, tunachukua hatua nyingine karibu na lengo hilo, ""alisema mkurugenzi wa NIAID Hugh Auchincloss, MD." "Mchunguzi wa ""FluMos-V2"" ulifanyika na watafiti wa Kituo cha Utafiti wa Chanjo cha NIAID." "Tiba hiyo ni marekebisho ya chanjo ya kwanza ya virusi vya mafua ya Flu, ""FluMos-V1,"" ambayo ilianza majaribio ya kwanza kwa binadamu mnamo 2021 na bado inapitia majaribio." FluMos2 imeundwa kuchochea antibodies dhidi ya aina nyingi tofauti za virusi vya mafua kwa kuonyesha sehemu ya virusi vya mafua hemagglutinin (HA) protini katika mifumo ya kurudia juu ya scaffolds ya nanoparticles ya kujikusanya. Kuambukizwa kwa vipande hivyo visivyo na madhara vya protini za virusi huandaa mfumo wa kinga kutambua na kupigana na virusi halisi. Wakati ulipojaribiwa kwenye wanyama, chanjo ya majaribio ilisababisha majibu ya nguvu ya kingamwili. Wakati chanjo ya FluMos-V1 inaonyesha HA kutoka kwa aina nne za virusi vya mafua, FluMos-V2 ina HA kutoka kwa sita: virusi vinne vya mafua A na virusi viwili vya mafua B. Watafiti wanatarajia kwamba hii itaongeza kinga ya wapokeaji wa chanjo, kutoa ulinzi dhidi ya aina mbalimbali za virusi vya mafua. Majaribio hayo yatatakiwa kuwahusisha wajitoleaji 24 wenye afya, wenye umri wa miaka 18 hadi 50, ambao watapokea sindano mbili za ndani ya misuli ya chanjo ya FluMos-V2. Injection hizi hufanywa kwa muda wa wiki 16. Kwa mfano, wagonjwa waliotajwa katika hatua ya kwanza walipewa kipimo cha chini (mg 60 kwa chanjo). Ikiwa hakuna wasiwasi wa usalama unaotambuliwa baada ya angalau washiriki watatu kupokea kipimo hiki, uandikishaji utaanza katika kikundi cha kipimo cha juu (180 mg kwa chanjo). Timu ya utafiti inapanga kuandikisha washiriki 12 katika kila kikundi cha kipimo. Kwa wiki 40 baada ya chanjo ya kwanza, washiriki watapokea simu za kufuatilia mara kwa mara na uchunguzi ili kufuatilia majibu yao kwa chanjo ya majaribio. Sampuli za damu zitachukuliwa wakati wa ziara za utafiti ili kupima majibu yoyote ya kinga kwa mgombea wa chanjo. Habari zaidi kuhusu jaribio hilo inapatikana kwenye ClinicalTrials.gov. Taarifa hii ya vyombo vya habari ilichapishwa awali kwenye tovuti ya Taasisi ya Kitaifa ya Madhara na Magonjwa ya Kuambukiza