Flu “patch” as effective as shots, preferred by patients

There are many reasons why patients might avoid vaccination, but the development of a new patch may help.

A microneedle patch (MNP) has been developed that does not require refrigeration or sharps disposal, could be mailed to patients for self-administration and may appeal to individuals who hate shots. The patch was tested through a Phase I clinical trial, and results were recently published in the Lancet in a study titled, “The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial.”

The clinical trial involved 100 adults aged 18 to 49 without significant dermatological disorders who had not yet received the 2014-2015 flu vaccine. Participants were split into four groups-those vaccinated with inactivated influenza vaccine through a MNP applied by a healthcare provider; participants who self-administered a MNP; those vaccinated with an intramuscular injection given by a healthcare provider; and those given a placebo MNP by a healthcare provider.

The trial was completed by researchers at Emory University and the Georgia Institute of Technology. Participants were treated and monitored at the Hope Clinic of the Emory Vaccine Center in Atlanta.

Nadine Rouphael, MD, an associate professor of medicine in the division of infectious diseases at Emory and lead investigator for the trial, said the patch could allow patients to self-administer the vaccine at home without any special needs such as refrigeration or sharps disposal.

“Because the MNPs are easy to use, stable at room temperature and leave no sharp waste, they are ideal for self-administration outside the healthcare system,” Rouphael told Medical Economics. “When patients can self-administer the microneedle patch from the comfort of their home without any special need, it has the potential to improve access to flu vaccines and therefore coverage.”

The safety profile of the MNP is similar to traditional vaccination via syringe, she said, and the immune response is comparable as well.
“The immune response is similar to the regular flu shot. The skin is an immunologically rich organ and therefore potentially a better target for many vaccines,” Rouphael said.

No treatment-related serious adverse events or new-onset chronic illnesses were observed in the study group, according to the report. Sixteen of the 25 patients who received intramuscular injections during the trial reported tenderness, and 11 out of 25 reported pain. In contrast, 33 out of 50 patients vaccinated with the MNP reported tenderness, 20 out of 50 reported erythema, and 41 out of 50 reported pruritus.

In terms of antibody response, titer levels at day 28 post-vaccination were similar in participants vaccinated with an intramuscular injection and with the MNP-administered either by a healthcare provider or self-administered by the participant. Seroconversion rates were significantly higher at day 28 after microneedle patch vaccination compared with placebo and were similar to vaccinations given via intramuscular injection, according to the report.

Next: Possible boost to vaccinations

Possible boost to vaccinations

Despite efforts to increase uptake of the flu vaccine, compliance among adults is only about 40%, according to the Centers for Disease Control and Prevention (CDC). People may avoid the flu vaccine for a number of reasons, but researchers say a tool like the MNP could remove barriers in patients who miss the vaccine due to access, inconvenience, or an aversion to shots. Traditional vaccines require refrigeration and must be administered with a syringe by a healthcare provider. The MNP could be distributed in a variety of ways, but patients may even be able to pick up the patch at a store, apply it at home themselves, then dispose of it safely after administration since the microneedles dissolve into the skin and require no special sharps disposal. Without the requirement of refrigeration, the MNPs could even be mailed to patients, according to researchers. According to the report, the patches could safely remain viable without refrigeration for up to a year.

The adhesive patches are fitted with dissolvable microneedles that researchers found were just as safe and effective as traditional vaccination techniques using needles or syringes. Additionally, participants in the study who received the MNP indicated a strong preference for the patch over traditional vaccination methods, with more than 70% of patients who used the MNP indicating a preference over intramuscular or intranasal vaccination.

Researchers are looking to extend trials of the MNP a greater number of participants and to children next, and are currently recruiting children under age two to test a placebo MNP in the hopes of developing a vaccine delivered through MNP within five years. They are also investigating other uses for the MNP, including for vaccination against diseases like measles, polio and rubella.