Enterovirus 71 Vaccine Is Safe and Efficacious.


Two doses of an enterovirus 71 vaccine had an efficacy of 80% against EV71-associated disease in Chinese children.

 

Enterovirus 71 (EV71) is associated with hand, foot, and mouth disease (HFMD) and other, more-serious conditions. Infants and young children are most affected; epidemics have been especially severe in Asia (JW Infect Dis Jan 30 2013).

Investigators (with partial manufacturer support) recently conducted a multicenter, double-blind, phase III trial of an inactivated alum-adjuvanted EV71 vaccine based on genotype C4, the predominant strain in mainland China. Healthy children in that country, aged 6 to 35 months, were randomized to receive vaccine or placebo (alum adjuvant), administered on days 0 and 28. Of 10,245 enrollees, 96% received both doses.

During active surveillance (from day 56 to month 14), vaccine efficacy in the per-protocol population was 80% against EV71-associated disease and 90% against EV71-associated HFMD. Among 52 participants with laboratory-confirmed EV71-associated disease, 51 were seronegative; all EV71 isolates were genotype C4. Eight placebo-group and no vaccine-group participants were hospitalized for EV71-associated disease. Most participants with clinical HFMD were infected with Coxsackie A virus 16 or other enteroviruses; only 2.1% of episodes were associated with EV71. In the subset studied for immunogenicity, antibody titer was significantly higher in vaccine-group than placebo-group participants. The rate of serious adverse events was similar between groups (1.2% and 1.5%, respectively).

Comment: The authors caution that although EV71 vaccine could help to prevent severe cases of EV71-associated disease, its role in reducing the overall incidence of hand, foot, and mouth disease might be limited because EV71 is only one cause of this syndrome. They also note the need to assess whether the vaccine’s immunogenicity and efficacy are affected by concomitantly administered routine vaccines. Editorialists observe that future studies should examine cross-protection against other genotypes and — because neonatal EV71 infection can be particularly severe — vaccination of infants aged <6 months. Cost-effectiveness analyses can help in setting priorities among the several new vaccines that are efficacious and have acceptable safety profiles.

 

Source: Journal Watch Infectious Diseases

Hand, foot and mouth disease: First vaccine.


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The first vaccine which protects children against hand, foot and mouth disease has been reported by scientists in China.

The infection causes a rash and painful blisters, but in some cases results in brain infections which can be fatal.

A trial involving 10,000 children, published in the Lancet, showed the vaccine was 90% effective against one virus which causes the disease.

It does not protect against other viruses that result in the disease.

Viruses can cause large outbreaks of hand, foot and mouth disease. In 2009, there was an outbreak in China involving 1.2 million people. Nearly 14,000 people had severe complications and 353 people died.

Groups of researchers in Jiangsu province and Beijing tested a vaccine made from a deactivated enterovirus 71 (EV71), which causes the disease.

Two jabs were given to children between six and 35 months old. They prevented 90% of cases of hand, foot and mouth disease caused by EV71.

“Infection with EV71 is of particular concern because it can cause severe disease and even death in children. The EV71 vaccine could help prevent hospital admissions and severe cases,” the researchers said.

Hand, foot and mouth disease is caused by many other viruses, such as Coxsackievirus A16 and even other strains of EV71, so this vaccine could not eliminate the disease.

The researchers themselves warn that: “The EV71 vaccine might have little part in reducing the overall incidence of HFMD, even by universal mass immunisation of children.”

Commenting on the research, Dr Nigel Crawford and Dr Steve Graham, both from the University of Melbourne, said the vaccine was tailored to the predominant strain in China.

“The major effect of this vaccine will be to reduce hospital admission, which is an important result of many vaccines.

“The next step is to assess the appropriateness of including an EV71 vaccine in China’s national immunisation programme.”

 

Source: BBC

Coxsackievirus A6 Causing Severe Hand, Foot, and Mouth Disease in U.S.


Coxsackievirus serotype A6 — previously reported only outside the U.S. — is now causing severe cases of hand, foot, and mouth disease (HFMD) here, according to an MMWR article. HFMD in the U.S. is typically caused by serotype A16.

From November 2011 to February 2012, the CDC was contacted regarding 63 people with HFMD or with fever and unusual rash for whom diagnostic assistance was needed. The cases occurred in Alabama, California, Connecticut, and Nevada. Three-quarters of clinical specimens tested positive for coxsackievirus A6; the rest were negative for all enteroviruses.

Among the 63 patients, rash and fever were more severe and hospitalization was more frequent than with typical HFMD. Fever occurred in 76%. Rash was noted on the hands or feet or in the mouth (67%), on the arms or legs (46%), face (41%), buttocks (35%), and trunk (19%). Almost 20% of patients were hospitalized.

The CDC is continuing to receive reports of coxsackievirus A6–associated illness.

Source: MMWR