Double-dose pneumococcal vaccine boosts immune response in patients with AAV on rituximab
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PHILADELPHIA — An initial double dose of pneumococcal vaccine improves immune response against pneumococcal pneumonia in patients with ANCA-associated vasculitis treated with rituximab, according to data presented at ACR Convergence 2022.
“The prognosis of [patients with ANCA-associated vasculitis (AAV)] has dramatically improved during the last two decades thanks to the use of new treatments like rituximab, which deplete B cells,” Benjamin Terrier, MD, a professor of medicine at Cochin Hospital at Paris Cité University, said during a press conference. “We still see morbidity and mortality in these patients, which is not really now related to vasculitis, but a complication of the treatment and especially infection, and so it’s very important to improve the protection for patients using these treatments.
“Usually whenever infection is the most frequent complication, in terms of infection, we have some vaccines, especially the flu vaccine or the pneumococcal vaccines, that are able to try to improve the protection of our patients,” he added.
In a multicenter, randomized, open-label, phase 2 trial, Terrier and colleagues evaluated two innovative “reinforced” anti-pneumococcal vaccine strategies to the standard of care for adult patients with newly diagnosed or relapsing AAV who received rituximab (Rituxan, Genentech).
The researchers randomized patients in a 1:1:1 ratio to either standard regimen combining a dose of the 13-valent pneumococcal conjugate vaccine (PCV13) at day 0 followed by a dose of 23-valent pneumococcal polysaccharide vaccine (PPV23) at month 5, a double dose of PCV13 at day 0 and day 7 followed by a dose of PPV23 at month 5, or four doses of PCV13 at day 0 followed by a dose of PPV23 at month 5.
The primary endpoint was the immune response at 6 months against 12 serotypes of Streptococcus pneumoniae common to the PCV13 and PPV23 vaccines: 0-3, 4-6, 7-9 or 10-12 serotypes, with secondary endpoints including local and systemic reactions 7 days after each vaccination, as well as any adverse events possibly related to immunization.
According to study results, patients who received a double dose of PCV13 followed by a later dose of PPV23 after 5 months were more significantly likely to occupy higher response categories vs. standard care, and achieved “a fourfold increase in protection compared to the standard of care,” Terrier said.
Patients who received the double dose experienced improved responses to 0-3 (56.3%), 4-6 (28.1%), 7-9 (15.6%) or 10-12 (0%) serotypes of pneumococcal pneumonia, compared with the standard of care, whereas patients who received the four doses of PCV13 at day 0 followed by the later dose of PPV23 at 5 months only experienced improved vaccine responses (pOR = 3.1; 97.5% CI, 0.8-11.9).
The researchers observed a higher number of local and/or systemic solicited reactions related to vaccine immunization among patients who received the “reinforced first vaccinations,” but consisted mainly of grade 1 or 2 local reactions. Terrier and colleagues reported eight vasculitis flares among six patients following the last vaccination: one patient in the standard care group, two patients in the double-dose group and three patients in the four-dose group.
“We still have to see if this better protection will be maintained during the follow up, and if it will decrease the rate of infection,” Terrier said. “I think [these results] would be interesting not only for the pneumococcal vaccine, but for other vaccines such as COVID-19 vaccine, and it will be also useful not only for vasculitis care but in many different diseases for which we use B-cell depleting agents, especially rituximab.”
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Terrier B. Abstract L16. Presented at: ACR Convergence 2022; Nov. 11-14, 2022; Philadelphia (hybrid meeting).
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