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Investigational nasal pertussis vaccine shows promise
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An intranasal Bordetella pertussis vaccine appears to be safe and effective in colonized adults, according to researchers from Sweden and France.
These positive findings indicate that the vaccine made from BPZE1, a genetically modified B. pertussis strain, may ultimately be useful in controlling pertussis in the target population, newborns.
In the double blind, placebo-controlled, dose-escalating, phase 1 clinical study, researchers enrolled 48 healthy men aged 19 to 31 years. The participants were randomly assigned to one of three BPZE1 dosage groups, with placebo patients apportioned equally in each 12-person group. The low-dose group consisted of 16 participants, two of whom were openly administered the active vaccine, 10 who received the active vaccine and four who were given placebo. The medium-dose and high-dose groups also each had 16 patients, with two patients openly receiving active vaccine, 10 receiving the active vaccine and four receiving placebo.
The researchers took blood samples at 2 to 6 weeks before vaccination, on the day of vaccination, and at 1, 2 and 4 weeks and 5 to 6 months after vaccination. Nasal aspirates also were collected at days 4, 7, 11, 14, 28 and, if needed, 45 after vaccination, to evaluate colonization by BPZE 1 of the nasopharyngeal mucosa.
The researchers found that the vaccine achieved colonization in one participant in the low-dose group, one in the medium-dose group and five in the high-dose group. In all colonized participants, there were significant increases in immune response against pertussis antigens. One serious adverse event was observed, but this was not related to the vaccine. The other adverse events were considered negligible and were seen with the same frequency in placebo and vaccine groups.
The researchers said before the BPZE 1 vaccine can be safely used in the target population of newborns, further tests must be conducted in older populations, such as children and adolescents.
“The steps required to reach the target population strongly depend on the decisions made by the regulatory agencies of countries in which these trials can be performed,” the researchers wrote. “Discussions with several of these are currently under way.”
Disclosure: See the full study for a list of researchers’ relevant disclosures.
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