Biomaterial Database

Clinical evaluation of neuraminidase monospecific (HEqN2) recombinant influenza vaccine in children. 1976

K R Beutner, and C Rizzone, and S DeMello, and P L Ogra

Phased clinical trials were undertaken to evaluate the efficacy of neuraminidase specific recombinant (HEqN2) inactivated influenza vaccine in a population of school children. Groups of subjects were immunized under code, with influenza A2 Port Chalmer (H3N2), Port Chalmer neuraminidase recombinant (HEqN2), and placebo vaccines (vaccine diluent) before the onset of A2 strain influenza epidemic in this population. Preliminary results have provided the following information. Immunization with commercial Port Chalmer (H3N2) or neuraminidase recombinant influenza A2 (HEqN2) vaccines, in a childhood population was safe and without any major adverse effects. Vaccination with H3N2 vaccine regularly induced seronconversion for specific hemagglutination-inhibiting (HAI) antibodies in over 60% of vaccinated subjects. The mean titers of antineuraminidase antibody (ANAB) in H3N2 recipients who were seropositive prior to immunization increased five-fold while the ANAB titers of individuals who were seronegative prior to immunization did not rise significantly after immunization. On the other hand, immunization with HEqN2 vaccine resulted in little or no HAI response against H3, while specific ANAB response was observed in over 70% of such vaccines. The ANAB titers increased approximately 10 fold in the vaccines who were seropositive prior to immunization, and the titers in subjects seronegative prior to immunization were 5-6 fold higher than the post immunization titers observed in seronegative individuals in the H3N2 vaccinated group. Preliminary data on protection against natural reinfection suggested that, although the incidence of serological reinfection was similar in all vaccine groups, the expression of clinical disease was somewhat milder in HEqN2 vaccinees and in individuals with high levels of ANAB. These studies provide tentative support to the potential use of neuraminidase specific vaccine for mass immunoprophylaxis against influenza A2 virus.

UI	MeSH Term	Description	Entries
D007251	Influenza, Human	An acute viral infection in humans involving the respiratory tract. It is marked by inflammation of the NASAL MUCOSA; the PHARYNX; and conjunctiva, and by headache and severe, often generalized, myalgia.	Grippe,Human Flu,Human Influenza,Influenza in Humans,Influenza,Flu, Human,Human Influenzas,Influenza in Human,Influenzas,Influenzas, Human
D007252	Influenza Vaccines	Vaccines used to prevent infection by viruses in the family ORTHOMYXOVIRIDAE. It includes both killed and attenuated vaccines. The composition of the vaccines is changed each year in response to antigenic shifts and changes in prevalence of influenza virus strains. The flu vaccines may be mono- or multi-valent, which contains one or more ALPHAINFLUENZAVIRUS and BETAINFLUENZAVIRUS strains.	Flu Vaccine,Influenzavirus Vaccine,Monovalent Influenza Vaccine,Universal Flu Vaccine,Universal Influenza Vaccine,Flu Vaccines,High-Dose Trivalent Influenza Vaccine,Influenza Vaccine,Influenza Virus Vaccine,Influenza Virus Vaccines,Influenzavirus Vaccines,Intranasal Live-Attenuated Influenza Vaccine,LAIV Vaccine,Monovalent Influenza Vaccines,Quadrivalent Influenza Vaccine,Trivalent Influenza Vaccine,Trivalent Live Attenuated Influenza Vaccine,Universal Flu Vaccines,Universal Influenza Vaccines,Flu Vaccine, Universal,High Dose Trivalent Influenza Vaccine,Influenza Vaccine, Monovalent,Influenza Vaccine, Quadrivalent,Influenza Vaccine, Trivalent,Influenza Vaccine, Universal,Intranasal Live Attenuated Influenza Vaccine,Vaccine, Flu,Vaccine, Influenza,Vaccine, Influenza Virus,Vaccine, Influenzavirus,Vaccine, LAIV,Vaccine, Monovalent Influenza,Vaccine, Quadrivalent Influenza,Vaccine, Trivalent Influenza,Virus Vaccine, Influenza
D009439	Neuraminidase	An enzyme that catalyzes the hydrolysis of alpha-2,3, alpha-2,6-, and alpha-2,8-glycosidic linkages (at a decreasing rate, respectively) of terminal sialic residues in oligosaccharides, glycoproteins, glycolipids, colominic acid, and synthetic substrate. (From Enzyme Nomenclature, 1992)	Sialidase,Exo-alpha-Sialidase,N-Acylneuraminate Glycohydrolases,Oligosaccharide Sialidase,Exo alpha Sialidase,Glycohydrolases, N-Acylneuraminate,N Acylneuraminate Glycohydrolases,Sialidase, Oligosaccharide
D009518	New York	State bounded on the north by Lake Ontario and Canada, on the east by Vermont, Massachusetts, and Connecticut, on the south by the Atlantic Ocean, New Jersey, and Pennsylvania, and on the west by Pennsylvania, Lake Erie, and Canada.
D009975	Orthomyxoviridae	A family of RNA viruses causing INFLUENZA and other respiratory diseases. Orthomyxoviridae includes INFLUENZAVIRUS A; INFLUENZAVIRUS B; INFLUENZAVIRUS C; INFLUENZAVIRUS D; ISAVIRUS; and THOGOTOVIRUS.	Influenza Viruses,Myxoviruses,Orthomyxoviruses,Influenza Virus,Myxovirus,Orthomyxovirus
D009980	Influenza A virus	The type species of the genus ALPHAINFLUENZAVIRUS that causes influenza and other diseases in humans and animals. Antigenic variation occurs frequently between strains, allowing classification into subtypes and variants. Transmission is usually by aerosol (human and most non-aquatic hosts) or waterborne (ducks). Infected birds shed the virus in their saliva, nasal secretions, and feces.	Alphainfluenzavirus influenzae,Avian Orthomyxovirus Type A,FLUAV,Fowl Plague Virus,Human Influenza A Virus,Influenza Virus Type A,Influenza Viruses Type A,Myxovirus influenzae-A hominis,Myxovirus influenzae-A suis,Myxovirus pestis galli,Orthomyxovirus Type A,Orthomyxovirus Type A, Avian,Orthomyxovirus Type A, Human,Orthomyxovirus Type A, Porcine,Pestis galli Myxovirus,Fowl Plague Viruses,Influenza A viruses,Myxovirus influenzae A hominis,Myxovirus influenzae A suis,Myxovirus, Pestis galli,Myxoviruses, Pestis galli,Pestis galli Myxoviruses,Plague Virus, Fowl,Virus, Fowl Plague
D002648	Child	A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL.	Children
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004196	Disease Outbreaks	Sudden increase in the incidence of a disease. The concept includes EPIDEMICS and PANDEMICS.	Outbreaks,Infectious Disease Outbreaks,Disease Outbreak,Disease Outbreak, Infectious,Disease Outbreaks, Infectious,Infectious Disease Outbreak,Outbreak, Disease,Outbreak, Infectious Disease,Outbreaks, Disease,Outbreaks, Infectious Disease
D004341	Drug Evaluation	Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.	Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation